Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
EARSCAN DSP-1 PURE TONE AUDIOMETER (K913589)Micro Audiometrics Corp.1991-11-05
AUTOMATIC CORNEAL SHAPER (K913697)Hansa Research & Development, Inc.1991-11-05
ORTHOPANTOMOGRAPH 100 (K912893)Instrumentarium Corp.1991-11-05
IN-THE-EAR HEARING AIDS (K913366)Fenwick Hearing Instruments1991-11-05
LYME-CHECK(TM) TEST KIT (K896378)Diagnostic Technology, Inc.1991-11-05
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE (K914448)W. L. Gore & Associates, Inc.1991-11-05
FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP (K913786)Abbott Laboratories1991-11-05
ELECTROSURGICAL UNIT CABLE (K913514)Kirwan Surgical Products, Inc.1991-11-05
TEGWIRE (TM) (K913391)Boston Scientific Corp1991-11-05
MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR (K913577)Control-X, Inc.1991-11-05
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE (K914450)W. L. Gore & Associates, Inc.1991-11-05
MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM (K913837)Vision Medical, Inc.1991-11-05
APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 (K913098)Dlp, Inc.1991-11-05
ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES (K912250)Theta Systems, Inc.1991-11-05
SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM (K912909)Air-Shields Vickers, Inc.1991-11-05
STAYFREE(TM) MAXI-PAD (K913747)Personal Products Co.1991-11-05
PGK STEREOTACTIC DEVICE (K911974)Northern Virginia Radiology and Nuclear Medicine1991-11-05
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 (K913764)Em Diagnostic Systems, Inc.1991-11-05
TORQUE FITTING (K912969)Freedom Machine, Inc.1991-11-05
ISOLATE INFUSION CATHETR SYSTEM (K913517)Lake Region Mfg., Inc.1991-11-05
INFU.DISK (K904619)Electrochemical Drug Delivery, Inc.1991-11-05
HEARING AID, UNITRON MODEL VISTA 3000 (K914688)Unitron Industries, Inc.1991-11-05
MODEL 520A NOVAMETRIX PULSE OXIMETER (K913516)Novametrix Medical Systems, Inc.1991-11-04
XKNIFE RADIOSURGERY SYSTEM (K912630)Rsa, Inc.1991-11-04
NORTEC CONNECTING TUBE SET (K911865)North American Sterilization & Packaging Co.1991-11-01
TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC (K913495)Telex Communications, Inc.1991-11-01
MICRO-AIRE MODEL 2060 (K913369)Micro Surgical Instruments Corp.1991-11-01
SMOKE/ODOR EVACUATOR #757 (K912612)Olsen Electrosurgical, Inc.1991-11-01
ER-1000 CATHERIZATION C-ARM SYSTEMS (K914348)Shimadzu Medical Systems1991-11-01
SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS (K913526)Althin Medical AB an Affiliate of Baxter Intl1991-11-01
40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE (K913325)Resonex, Inc.1991-11-01
BONE-TEMNO/STERNUM-TEMNO (K913306)Proact, Ltd.1991-11-01
NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE (K913999)American Surgical Instruments Corp.1991-11-01
DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY (K913950)Althin Medical AB an Affiliate of Baxter Intl1991-11-01
HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE (K913264)Mallinckrodt Group, Inc.1991-11-01
ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET (K913911)Roche Diagnostic Systems, Inc.1991-11-01
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER (K913321)Hologic, Inc.1991-11-01
SURGI-SPRAY O.R. IRRIGATION SYSTEM (K913568)Phoenix Surgical Products, Inc.1991-11-01
MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31) (K914019)Hitachi Medical Systems America, Inc.1991-11-01
MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR (K913578)Control-X, Inc.1991-11-01
LASER ENDOSCOPE DISC DECOMPRESSION KITS (K913136)Medical Laser, Inc.1991-11-01
ENEMA KIT (K913620)York County Blind Center1991-11-01
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES (K914509)Roche Diagnostic Systems, Inc.1991-11-01
TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC (K913494)Telex Communications, Inc.1991-11-01
K-SOL(TM) (K911587)Alcon Laboratories1991-11-01
ENDOSTAT ELECTROSURGICAL UNIT (K913881)Medical and Scientific Enterprises, Inc.1991-11-01
ACUSON V510 TRANSDUCER (K911767)Acuson Corp.1991-10-31
DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH (K913235)Davol, Inc.1991-10-31
MEGA ANGIOGRAM KIT (K913397)Mega Medical, Inc.1991-10-31
SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION (K911761)S & W Medico Teknik1991-10-31
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS (K913451)Hewlett-Packard Co.1991-10-31
QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE (K914672)Medicotest, Inc.1991-10-31
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT (K912748)Binax, Inc.1991-10-31
MONOCLONAL ANTIBODY ANTI-CD5 (K901188)Sigma Chemical Co.1991-10-31
CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC (K910473)Coulter Immunology1991-10-31
MONOCLONAL ANTIBODY ANTI-CD2 (K901187)Sigma Chemical Co.1991-10-31
MEGA ARTHROGRAM KIT (K913317)Mega Medical, Inc.1991-10-31
CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY (K910530)Heraeus Lasersonics, Inc.1991-10-31
OIA STREP A (K912889)Biosearch Medical Products, Inc.1991-10-31
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 (K912807)Em Diagnostic Systems, Inc.1991-10-31
ACLAIMS-IS (K912085)W-Technology1991-10-31
SODIUM REAGENT SET (K914039)Sterling Diagnostics, Inc.1991-10-31
MONOCLONAL ANTIBODY ANTI-CD19 (K901186)Sigma Chemical Co.1991-10-31
TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST (K912045)Lifestream Int'L, Inc.1991-10-31
THROMBONOSTIKA F1.2 (K911434)Organon Teknika Corp.1991-10-31
MONOCLONAL ANTIBODY ANTI-CD3 (K901189)Sigma Chemical Co.1991-10-31
FUJI II LC (K913884)G-C Intl. Corp.1991-10-30
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL (K914469)Cholestech Corp.1991-10-30
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K913475)GE Medical Systems1991-10-30
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED (K913718)Abbott Laboratories1991-10-30
URS-HYDRO-DILATOR MODEL NUMBER 2164.00 (K912331)Richard Wolf Medical Instruments Corp.1991-10-30
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT (K911315)Baxter Healthcare Corp1991-10-30
GEN-X 800/650 (K914302)Swissray Finatech, Inc.1991-10-30
SIEMENS MICRO2 PULSE OXIMETER (K913489)Siemens Medical Electronics1991-10-30
MICRONAIRE ISO-HOOD MAX 5UV (K912142)Micronaire Corp.1991-10-30
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES (K914468)Roche Diagnostic Systems, Inc.1991-10-30
PANCRETEC I.V. MODEL 5500 INFUSER (K913719)Abbott Laboratories1991-10-30
PEEPERS TANNING GOGGLES (K914095)California Suncare, Inc.1991-10-30
HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST (K913757)Hologic, Inc.1991-10-30
COFFMAN TOMOGRAPH (K913652)Coffman Dental1991-10-30
TROCAR (K914377)O.R. Concepts, Inc.1991-10-30
SMT-100X (K911975)Shimadzu Medical Systems1991-10-30
INFUCARE SYRINGE PUMP TUBING SET (K914034)Infucare Products, Inc.1991-10-30
MINIFLEX AND PERSONAL UNIT (K912997)Dabi-Atlante America Corp.1991-10-30
PHOSPHOLIPID REAGENT SET (K914040)Sterling Diagnostics, Inc.1991-10-30
SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (K914120)Conmedcorp1991-10-30
C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM (K912910)Air-Shields Vickers, Inc.1991-10-30
ASPIRATION/INJECTION NEEDLE (K913992)Northgate Technologies, Inc.1991-10-30
TCAL ABUTMENT (K913782)Core-Vent Corp.1991-10-30
GEN-X 800/800 (K914301)Swissray Finatech, Inc.1991-10-30
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED (K913720)Abbott Laboratories1991-10-30
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 (K913058)Helena Laboratories1991-10-30
CARDIOFOCAL COLLIMATOR (K914179)Siemens Gammasonics, Inc.1991-10-30
CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED (K912030)3M Company1991-10-30
AUTOMATED BIOPSY DEVICE, MODIFICATION (K913815)Hart Enterprises, Inc.1991-10-30
AESCULAP TITANIUM BONE SCREWS (K913415)Aesculap, Inc.1991-10-29
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF (K912604)Aries Medical, Inc.1991-10-28
PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT (K913760)Psoralite Corp.1991-10-28
DERMASAFE(TH) HYPOALLERGENIC (K914094)Multi-Com Sdn Bhd1991-10-28
C1 RID KIT (K914388)The Binding Site, Ltd.1991-10-28
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Track 1991 automatically

Every clearance here is in the API, with alerts when new ones post.