Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COMFORTONE PHS (K960741)Comfortone America'S Value Hearing Aid Line1996-05-07
DIGITAL IMAGE ACQUISITION SYSTEM (K950330)International Imaging Electronics1996-05-07
ECHONET (K960946)Lockheed Martin Communications Systems1996-05-07
HM-88011 SOLID STATE ELECTR SURGICAL UNIT (K961473)Hill-Med, Inc.1996-05-07
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND (K955635)Welch Allyn, Inc.1996-05-07
GRAHAM-FIELD CONDUCTIVE ECG SPRAY (K944599)Chester Labs, Inc.1996-05-07
ORTHOFAB WHEELCHAIR (K952675)Orthofab, Inc.1996-05-07
KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME (K961244)KARL STORZ Endoscopy-America, Inc.1996-05-07
CODEMASTER XL + XL W/SHOCK ADVISORY OPTION (K954957)Hewlett-Packard Co.1996-05-07
ECHO-COM FOR MS-WINDOWS VERSION 2.0 (K960665)Cone Instruments, Inc.1996-05-07
CYSTOSCOPE 0/15/30/70 DEGREES (K960872)Pollux Endoscopy, Inc.1996-05-07
DSL ACTIVE I-HCG IRMA (K960357)Diagnostic Systems Laboratories, Inc.1996-05-07
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE (K961226)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
AUDIO 'D' INTIMA CIC (K961308)Hearing Solutions, Inc.1996-05-07
CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (K952966)Nidek Medical Products, Inc.1996-05-07
BCW ADVANTAGE WHEELCHAIR (K961514)Wheelchairs of Kansas1996-05-07
GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL (K944598)Chester Labs, Inc.1996-05-07
ACUMED BONE GRAFT SYSTEM (K960711)Acu Med, Inc.1996-05-07
EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) (K961115)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 (K961143)Telex Communications, Inc.1996-05-07
ULTRA COMPACT VIDEO IMAGER (K953165)International Imaging Electronics1996-05-07
ADVANTX LCV+ (K960575)GE Medical Systems1996-05-07
CORD WRAP WITH NEEDLE RESHEATHER (K960963)Osborn Medical Corp.1996-05-06
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) (K961043)Scantibodies Laboratory, Inc.1996-05-06
COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) (K960178)Wembley Rubber Products (M) Sdn Bhd1996-05-06
ULTRACID AND ULTRACID F DISINFECTING SOLUTION (K960697)Ultradent Products, Inc.1996-05-06
CERTI COOL INSTANT COLD COMPRESS (K960624)Certified Safety Mfg., Inc.1996-05-06
SARGON IMMEDIATE LOAD IMPLANT (K961005)Graham & James1996-05-06
LCX NEISSERIA GONORRHOEAE ASSAY (K935833)Abbott Laboratories1996-05-06
BARBITURATE SERUM TOX EIA ASSAY (K960664)Diagnostic Reagents, Inc.1996-05-06
VITAFLOW SUCTION/ASPIRATION TUBING SET (K960616)Vital Concepts, Inc.1996-05-06
POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133 (K961474)Medtronic Minimed1996-05-06
OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW (K955332)Opti-Max1996-05-06
THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS (K955282)Thermogenesis Corp.1996-05-06
SNAPDOSE DEVICE (K955410)Abbott Laboratories1996-05-06
CERCLAGE WIRE CRIMP BLOCK (K960651)Acu-Med, Inc.1996-05-03
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES (K954221)Hartalega Sdn Bhd1996-05-03
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR (K950484)Bird Products Corp.1996-05-03
DDS SPINAL SYSTEM (K960107)Encore Orthopedics, Inc.1996-05-03
AESOP SYSTEM AND ACCESSORIES (K960655)Computer Motion, Inc.1996-05-03
AS/3 COMPACT AIRWAY MODULE M-CAIOV (K960490)Datex Medical Instrumentation, Inc.1996-05-03
IMMUNO DOT BORRELIA DOT BLOT G TEST (K953682)Genbio1996-05-03
BURCH/SCHNEIDER REINFORCEMENT CAGE (K960678)Intermedics Orthopedics1996-05-03
BURDICK 200 PULSE OXIMETER (K954267)Burdick, Inc.1996-05-03
BIO-DRESSING, STERILE ISLAND DRESSING (K961098)K. W. Griffen Co.1996-05-03
TANGENT VI TABLE (K961022)Fischer Imaging Corp.1996-05-03
OPTIBLAST INTRAORAL SANDBLASTER (K955573)Buffalo Dental Mfg. Co., Inc.1996-05-03
MMUNO DOT BORRELIA DOT BLOT M TEST (K953683)Genbio1996-05-03
RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY (K955684)Contour Fabricators of Florida, Inc.1996-05-02
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 (K961293)Consolidated Technologies, Inc.1996-05-02
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT (K954828)Gibeck, Inc.1996-05-02
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA (K960429)Smiths Industries Medical Systems, Inc.1996-05-02
ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT (K955707)Excel Scientific, Inc.1996-05-02
22 MM COCR HEAD & POLYETHLENE LINER (K960180)Stelkast Company1996-05-02
ABBOTT CELL-DYN 3500R SYSTEM (K960427)Sequoia Turner Corp.1996-05-02
ENA-C-T TOTAL CHOLESTEROL TEST (K960377)Actimed Laboratories, Inc.1996-05-02
TURBO TRACKER (K960806)Target Therapeutics1996-05-02
KETOREX C SANWA (K953452)Ihara Medics U.S., Inc.1996-05-02
NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA (K934695)Intermedics Orthopedics1996-05-02
MARTECH ENDOSCOPIC INJECTION NEEDLE (K960519)Martech Medical Products, Inc.1996-05-01
MINISTICK PREGNANCY TEST (K960733)Vanguard Biomedical Corp.1996-05-01
SERUM TOX CALIBRATOR (K961372)Diagnostic Reagents, Inc.1996-05-01
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 (K955382)3M Company1996-05-01
KARL STORZ URETER RESECTOSCOPE (K960757)KARL STORZ Endoscopy-America, Inc.1996-05-01
ACCUTEMP PROBE (K960080)Kentec Medical, Inc.1996-05-01
INTEGRATOR (K950646)Moyco Union Broach, Div., Moyco Technologies, Inc.1996-04-30
STC DIAGNOSTICS AUTO-LYTE PH ASSAY (K954158)Solarcare Technologies Corp,Inc.1996-04-30
BRAUN HEMODIALYSIS BLOOD CIRCUITS (K952631)B.Braun Medical, Inc.1996-04-30
MINIMED INFUSION PUMP, MODEL MMT-507 (K960001)Medtronic Minimed1996-04-30
LM ANCHOR OR OTHER PROPRIETARY NAME (K960825)Li Medical Technologies, Inc.1996-04-30
GE ADVANTAGE WINDOWS REVIEW WORKSTATION (K960613)GE Medical Systems1996-04-30
V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER (K953300)Hdc Corp.1996-04-30
EMOX (K954506)Medtrak Intl., Inc.1996-04-30
SECURE EVA DUAL CHAMBER MIXING BAG (K960581)Secure Medical Products, Inc.1996-04-30
INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F) (K961135)C.R. Bard, Inc.1996-04-30
MODEL 200C ELECTROSURGICAL PROBE (K960695)Zomed Intl.1996-04-30
ARCO-MBC, ARCO MC (K954171)Holl Meditronics, Inc.1996-04-30
OLYMPUS KD SERIES SPHINCTEROTOME (K955247)Olympus America, Inc.1996-04-30
ZOMED 30F ELECTROSURGICAL PROBE (K960694)Zomed Intl.1996-04-30
DAUM BIOPSYNEEDLE (K961185)Ferguson Medical1996-04-30
LIGHTSOURCE OR ILLUMINATOR (K961074)Cuda Products Co.1996-04-30
MAYFIELD-ACCISS WORKSTATION (K955397)Nomos Corp.1996-04-30
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM (K954570)Ortho Diagnostic Systems, Inc.1996-04-30
TONOMETERED SLAINE BLOOD GAS CONTROL (K961441)Instrumentarium Corp.1996-04-30
SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES (K960563)Scimed Life Systems, Inc.1996-04-29
SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE (K960040)Sharplan Lasers, Inc.1996-04-29
AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE (K943145)The Monticello Group, Inc.1996-04-29
CLEARBLUE EASY (K960316)Unipath , Ltd.1996-04-29
ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 (K955093)Utah Medical Products, Inc.1996-04-29
PEDI VAGINAL ASPIRATOR (K954903)Cook Urological, Inc.1996-04-29
DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL (K960815)Dumex Medical Surgical Products, Ltd.1996-04-29
CARBOMEDICS MITRAL ROTATOR (K960923)Carbomedics, Inc.1996-04-29
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION (K960381)Elscint, Inc.1996-04-29
EBNA IGG EIA TEST SYSTEM (K951549)Immunoprobe, Inc.1996-04-29
SALICYLATE ASSAY (K961131)Diagnostic Reagents, Inc.1996-04-29
MILL-ROSE BLIND MICROBIOLOGY BRUSH (K960880)Mill-Rose Laboratory1996-04-29
SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE (K960657)Scimed Life Systems, Inc.1996-04-29
RAILWIRE (K954552)Boston Scientific /International Technologies1996-04-29
IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK (K954622)Boston Scientific /International Technologies1996-04-29
SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM (K960372)Scanlan Intl., Inc.1996-04-26
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Every clearance here is in the API, with alerts when new ones post.