Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST. (K921201)Med Institute, Inc.1992-07-21
WAKO AUTOKIT LIPASE-COLOR (K921249)Wako Chemicals USA, Inc.1992-07-21
GLYCOMAT HAEMOGLOBIN ANALYSER (K920198)Drew Scientific , Ltd.1992-07-21
EXCEL CT TWIN (K915738)Elscint, Inc.1992-07-21
DIA STRIPS SYSTEM, MODIFIED (K921495)Symcon Intl., Inc.1992-07-21
MODEL 600 MEDICAL TREATMENT TABLE (K923325)Tri W-G, Inc.1992-07-21
STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY (K922125)Baxter Diagnostics, Inc.1992-07-21
MPG 65-80-100 X-RAY GENERATOR AND CONTROL (K921951)General Electric Co.1992-07-21
OLYMPUS ISE MODULE (K921718)Olympus Corp.1992-07-21
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (K922031)Medtronic Hemotec, Inc.1992-07-21
PIM 1.0 LASER DOPPLER PERFUSION IMAGER (K920844)Lisca Development AB1992-07-21
COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE (K914136)Coherent Medical Group1992-07-21
KODAK EKTACHEM DT SLIDES (NBIL) (K921844)Eastman Kodak Company1992-07-21
PROTECTOR SYRINGE SAFETY CAP SYSTEM (K922158)Injectimed, Inc.1992-07-21
KAYE MODEL KIAO PELVIC/THIGH STABILIZER (K923095)Kaye Products, Inc.1992-07-21
SYNERMED UIBC REAGENT KIT (K922784)Synermed, Inc.1992-07-21
TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. (K921856)Schneider Intl., Ltd.1992-07-21
GENERAL SURGERY CLAMP AND NEEDLE HOLDER (K922659)Miltex Instrument Co.1992-07-21
MODEL SLASE 210 HOLMIUM LASER SYSTEM (K920248)Sunrise Technologies, Inc.1992-07-21
MODULAR ACETABULAR CUP SYSTEM (K920430)Smith & Nephew Richards, Inc.1992-07-21
EXAMINATION LAMP (K922150)Air-Shields, Inc.1992-07-21
NOVA 14 NA/K/CL/GLU/BUN ANALYZER (K922215)Nova Biomedical Corp.1992-07-17
GENESIS(TM) INFUSION SYSTEM (K911636)Norman'S1992-07-17
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL (K921252)Hybritech, Inc.1992-07-17
TMP MICROPLATING SYSTEM (K921458)Techmedica, Inc.1992-07-17
SUNRUNNER TE-777 (K923193)Pride Health Care, Inc.1992-07-17
OLYMPUS ALBUMIN REAGENT (K922369)Olympus Corp.1992-07-17
LX 150 LIGHT SOURCE (K922095)Welch Allyn, Inc.1992-07-17
PHILIPS DSI SYSTEM RELEASE 3.2 (K920793)Philips Medical Systems, Inc.1992-07-17
OLYMPUS URIC ACID REAGENT (K922756)Olympus Corp.1992-07-17
VISTA HPQ SYSTEM (K921881)Philips Medical Systems (Cleveland), Inc.1992-07-17
INTRAMEDULLARY HIP SCREW (K921786)Smith & Nephew Richards, Inc.1992-07-17
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET (K920556)Hybritech, Inc.1992-07-17
GENESYS II (K922080)Adac Laboratories1992-07-17
OXYGEN SENSING DEVICE, MODIFICATION (K913392)Devilbiss Health Care, Inc.1992-07-17
ACU-TRAIN V (5) (K920532)Sterne Medical Equipment Div. Ontario , Ltd.1992-07-17
STERI-OSS DRILLS AND TAPS (K915733)Steri-Oss, Inc.1992-07-17
STERILE/SINGLE USE SYMBLEPHARON RING (K921221)Storz Instrument Co.1992-07-17
BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR (K915321)Bt Medical Co., Inc.1992-07-17
CYNOSURE PHOTOTRIPTER LASER (K921840)Cynosure, Inc.1992-07-16
CBIS CATHETER PULL-BACK DEVICE (K921879)Cardiovascular Imaging Systems, Inc.1992-07-16
NEBULIZER (DIRECT PATIENT INTERFACE) (K915075)Medi Nuclear Corp., Inc.1992-07-16
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM (K921758)Storz Instrument Co.1992-07-16
STAT K SYSTEM (K915345)Portable Diagnostic Services, Inc.1992-07-16
MRT-50A QD SPINE COIL (K921720)Toshiba America Mri, Inc.1992-07-16
TESTPACK PLUS STREP A (K922345)Abbott Laboratories1992-07-16
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) (K921939)Heraeus Kulzer, Inc.1992-07-16
OLYMPUS TOTAL PROTEIN REAGENT (K922361)Olympus Corp.1992-07-16
GE 4096 PLUS & GE 2048 (K914267)GE Medical Systems1992-07-16
3M PRECISE BRAND INTERNAL SURGICAL STAPLES (K921051)3M Health Care, Ltd.1992-07-16
OLYMPUS GLUCOSE REAGENT (K922232)Olympus Corp.1992-07-16
MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM (K921801)Techmedica, Inc.1992-07-15
PRE-STERILIZED ITI DENTAL IMPLANTS (K920928)The Straumann Co.1992-07-15
DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL (K922387)Baxter Diagnostics, Inc.1992-07-15
INTRADUCER (K921934)Taut, Inc.1992-07-15
NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX (K920379)Novametrix Medical Systems, Inc.1992-07-15
HOOK SURGICAL INSTRUMENT (K920599)Origin Medsystems, Inc.1992-07-15
SLT LASER DELIVERY SYSTEM (K922634)Surgical Laser Technologies, Inc.1992-07-15
TETRIC LIGHT-CURING COMPOSITE (K922569)Ivoclar North America, Inc.1992-07-15
KING DIAGNOSTICS AST (GOT) REAGENT (K922108)King Diagnostics, Inc.1992-07-15
TOMEY PE-300 PORTABLE ERG (K921815)Tomey Corporation USA1992-07-15
ENDOBAG, MODIFICATION (K921709)Dexide, Inc.1992-07-14
SUCTION/IRRIGATION Y TUBING SET (K922655)Core Dynamics, Inc.1992-07-14
WAKO AUTOKIT MICRO TP (K920531)Wako Chemicals USA, Inc.1992-07-14
AMRAD HEL-PTEST (K920827)Amrad1992-07-14
ESP BLOOD CULTURE SYSTEM (K921637)Difco Laboratories, Inc.1992-07-14
DERMAGRAN WET DRESSING (ZINC-SALINE) (K913344)Derma Sciences, Inc.1992-07-14
DIASTAT ANTI-HISTONE KIT (K920616)Shield Diagnostics, Ltd.1992-07-14
ACCUTRACKER DX (K913844)Suntech Medical Instruments, Inc.1992-07-14
IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST (K922296)Ampcor, Inc.1992-07-14
NK MEDICAL MICROMETER, MODEL MC001 (K921266)Nk Biotechnical Engineering Co.1992-07-14
INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST (K922297)Ampcor, Inc.1992-07-14
BLOOD GAS/ISE LINEARITY CONTROL (K920285)Phoenix Diagnostics, Inc.1992-07-14
MONOTUBE EXTERNAL FIXATION SYSTEM (K910483)Howmedica Corp.1992-07-14
E-Z CLAMP#1 AND#2 (K922243)Southwest Medical Mfg., Inc.1992-07-14
UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER (K914538)Innovative Medical Products, Inc.1992-07-14
NK DYNA-GRIP SENSOR, MODEL DG001 (K921268)Nk Biotechnical Engineering Co.1992-07-14
HOT OR COLD PACK (THERMIPAQ) (K921446)Thermionics Corp.1992-07-13
INDUSTRIAL STRENGTH EYEWEAR (K920701)Grafix Marketing Group1992-07-13
LAPAROSCOPIC SURGICAL INSTRUMETNS (K921260)Jana Medical1992-07-13
OLYMPUS CREATINE KINASE REAGENT (K922459)Olympus Corp.1992-07-13
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX (K920795)Optical Radiation Corp.1992-07-13
SPINE LINE (K922366)Dambrecine, Inc.1992-07-13
TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (K922772)Biodan Medical Systems, Ltd.1992-07-13
TX ELECTRIC TOOTHBRUSH (K921773)Optiva Corp.1992-07-13
TUMBLE FORMS TRISTANDER (K922965)Tumble Forms1992-07-13
IRRIGATING SYRINGE (K912437)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-07-13
ULTRAGATER WHEELCHAIR LIFT (K922624)Crow River Industries, Inc.1992-07-13
FDP PLASMA TEST KIT (K920943)American Bioproducts Co.1992-07-13
INSUFFLATOR, LAPAROSCOPIC (K920959)Mectra Labs, Inc.1992-07-13
GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. (K915636)Associated Ent., Inc.1992-07-13
CVIS INSIGHT III SYSTEM (K921750)Cardiovascular Imaging Systems, Inc.1992-07-13
BIOLOR (K921772)Degussa AG1992-07-13
VERSA-VIAL (K920177)Bioteque America, Inc.1992-07-13
745-M (MAGNUM) (K922980)Tri W-G, Inc.1992-07-13
FLEXION DISTRATION SUPPORT (K921711)Altoona Medical Supply1992-07-13
DIGI SPORTLENS SYSTEM (K921444)Fitness Quest, Inc.1992-07-13
EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF (K914743)Pertrach1992-07-10
DSL ACTIVE ALDOSTERONE (DSL 8600) (K921205)Diagnostic Systems Laboratories, Inc.1992-07-10
COLUMNMATE II (K921676)Helena Laboratories1992-07-10
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Every clearance here is in the API, with alerts when new ones post.