Atlas FDA

1991

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

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RecordFirmDate
PRECISE BARND PI DISPOSABLE SURGICAL STAPLES (K911252)3M Medical Products Group1991-07-25
DISPOSABLE O.R. TOWEL (K912110)American Threshold Industries, Inc.1991-07-25
BRANEMARK SYSTEM-5.0MM FIXTURE (K911961)Nobelpharma USA, Inc.1991-07-25
GASPARAITIS ESOPHAGRAM CATHETER SET (K911897)E-Z-Em, Inc.1991-07-24
SFA-II MICROPROCESSOR-CONTROLLED MODULE (K910905)Life Sciences Manufacturing, Inc.1991-07-24
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR (K904899)Vital Signs, Inc.1991-07-24
SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID (K912665)Resound Corp.1991-07-24
ACCU-PLACER TM KIT (K912473)Hu-Friedy Mfg. Co., Inc.1991-07-24
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA (K912940)Diagnostic Products Corp.1991-07-24
SALTER LABS DISPOSABLE NIPPLE AND NUT (K912174)Salter Labs1991-07-24
ELITE II ELECTROCARDIOGRAPH (K904032)Burdick Corp.1991-07-24
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912489)Immuno Concepts, Inc.1991-07-24
ICON STREP B IMMUNOENZYMETRIC ASSAY (K911417)Hybritech, Inc.1991-07-24
HEPARIN ADSORBENT (K912061)Sigma Diagnostics, Inc.1991-07-24
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA (K912408)Meridian Diagnostics, Inc.1991-07-24
CROMATEST SYPHILIS DIAGNOSTIC (K904496)Biotrax, Inc.1991-07-24
BARD REPLACEMENT GASTROSTOMY TUBE (K910492)C.R. Bard, Inc.1991-07-24
E560 ELECTROCARDIOGRAPH (K903565)Burdick Corp.1991-07-24
PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT (K912256)Lee Pharmaceuticals1991-07-24
HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT (K912395)Howmedica Corp.1991-07-24
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912488)Immuno Concepts, Inc.1991-07-24
DC200 DEFIBRILLATOR (K910634)Siemens Burdick, Inc.1991-07-24
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE (K912208)Fresenius USA, Inc.1991-07-24
OPTYX (K904883)Baxter Healthcare Corp1991-07-24
SOFT TISSUE SUTURE WASHER/3 HOLE WASHER (K910229)Depuy, Inc.1991-07-24
SPINAL TAP NEEDLE (K910652)Gesco Intl., Inc.1991-07-24
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (K911640)Olympus Corp.1991-07-24
SALTER LABS NEONATAL NASAL OXYGEN CANNULA (K911740)Salter Labs1991-07-24
QUIKPAC-II ONE STEP PREGNANCY HOME TEST (K912316)Syntron Bioresearch, Inc.1991-07-24
PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS (K912542)Puritas Health Care, Inc.1991-07-23
MODEL 5866-9M & MODEL 6981M (K911827)Metronic, Inc.1991-07-23
TRIP(TM) NASOGASTRIC SUMP CATHETER (K911825)Tonometrics, Inc.1991-07-23
GENESYS AND THE ROI (K910002)The Complete Systems Corp. Genesys1991-07-22
HYPERLITE (K905168)S.O.S. , Ltd.1991-07-22
AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT (K912733)Amersham Corp.1991-07-22
FETALGARD 2000 (K910169)Analogic Corp.1991-07-22
BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF (K912007)Tecnadyne Scientific, Inc.1991-07-22
INFUSABLE (K911216)Biomedical Dynamics, Inc.1991-07-22
ANTIGENZ CHLAMYDIA (K912680)Baxter Diagnostics, Inc.1991-07-22
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH) (K912729)Syva Co.1991-07-22
PULSATILE ANTI-EMBOLISM SYS.PUMP (K911853)Baxter Healthcare Corp1991-07-22
ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE (K905752)Beacon Laboratories, Inc.1991-07-22
CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (K911935)Gould, Inc.1991-07-22
HUMAN C-REACTIVE PROTEIN RID KIT (K905633)The Binding Site, Ltd.1991-07-22
SURGICAL GLOVES (K910895)Influx Pacific Sdn. Bhd.1991-07-22
UNIQUANT (K905435)Neuroconcepts, Inc.1991-07-22
ADVANTAGE EP (K903734)Clark Davis Medical Systems, Inc.1991-07-22
BELSCOPE LARYNGOSCOPE (K904918)Avulunga Pty. , Ltd.1991-07-22
CMD/DLCO DIAGNOSTIC SPIROMETER (K911358)Spirometrics, Inc.1991-07-22
SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION (K912234)Somnitec, Inc.1991-07-22
THERAPY CHAIR SYSTEM (K910648)Radiation Technology, Inc.1991-07-22
3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT (K912225)3M Medical Products Group1991-07-22
POSEY CUFFLATOR (K912723)Posey Co.1991-07-20
ENTREE CANNULA (K911813)Core Dynamics, Inc.1991-07-19
MONOPOLAR SPHINCTERTOME (K911787)Everest Medical Corp.1991-07-19
MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K911991)Siemens Medical Solutions USA, Inc.1991-07-19
SURGICAL SAW BLADES (K912761)Blairden Precision Instruments, Inc.1991-07-19
PERRY NATURAL POWDER FREE GLOVES (K912797)Smith & Nephew, Inc.1991-07-19
X-MARX (K911873)Macbrud Corp. Medical Div.1991-07-19
MICRO ALBUMIN EIA TEST KIT (K912543)Immuno Diagnostic Center, Inc.1991-07-19
CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE (K911794)Cordis Corp.1991-07-19
CENTAURI/PEGASUS (K905802)Pfizer Laser Systems1991-07-19
SALTER LABS INFANT MEDIUM CONCENTRATION MASK (K912633)Salter Labs1991-07-19
IMMUNOCARD HCG ONE STEP (I-S) TEST KIT (K911826)Disease Detection International, Inc.1991-07-19
CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM (K911943)Burke, Inc.1991-07-19
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) (K912024)Wako Chemicals USA, Inc.1991-07-19
TARGET MICROALBUMINURIA TEST (K912246)Texas Immunology, Inc.1991-07-19
ROCHE REAGENT FOR C02 (K911838)Roche Diagnostic Systems, Inc.1991-07-19
ELECTROLYTE CONTROL (K912513)Verichem Laboratories, Inc.1991-07-19
LASER BEAM LOCALIZER FOR SIREMOBIL 4 (K912380)Siemens Medical Solutions USA, Inc.1991-07-19
OLYMPIC WARMETTE (K911955)Olympic Medical Corp.1991-07-19
CALCITONIN KIT MITSUBISHI YUKA (K912536)Mitsubishi Yuka America, Inc.1991-07-18
MAGNETIC HDL CHOLESTEROL TEST (K911906)Reference Diagnostics, Inc.1991-07-18
K-CAP-I, STERILE (K912762)Westcon Orthopedics, Inc.1991-07-18
INJECTOR FILL TUBE (K911549)The R Group1991-07-18
MODEL 8604-FO PULSE OXIMETER (K910001)Nonin Medical, Inc.1991-07-18
DATAMED MODEL 401A TRANSRECIEVER (K904966)Datamed, Inc.1991-07-18
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST (K912251)King Diagnostics, Inc.1991-07-18
FUTURECARE CARELYNK IV SYSTEM (K903512)Futurecare Systems, Inc.1991-07-18
IPI ALGO-LINE CATHETER (K911382)Pudenz-Schulte Medical Research Corp.1991-07-18
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX (K911501)Shimadzu Medical Systems1991-07-17
PX COULTER(R) CELL CONTROL (K912133)Coulter Electronics, Inc.1991-07-17
E-Z LIFT CRANK IMAGING TABLE (K912181)Med-Tron Products, Inc.1991-07-17
NOVA 12 ANALYZER (K912560)Nova Biomedical Corp.1991-07-17
GUM MASSAGER (K911418)Burn-Henderson Partnership1991-07-17
LINEARITY TEST KITS (K912441)Boehringer Mannheim Corp.1991-07-17
ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K912440)Home Diagnostics, Inc.1991-07-17
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 (K912386)Helena Laboratories1991-07-17
SYNERMED PHOSPHORUS REAGENT KIT (K912569)Synermed, Inc.1991-07-17
TRACE TOTAL/DIRECT BILIRUBIN REAGENT (K911866)Trace Scientific , Ltd.1991-07-17
AMERLITE CK-MB ASSAY (K912766)Amersham Corp.1991-07-17
MODELS 5,8,20,20S ARGON ION LASERS (K912438)Hgm Medical Laser Systems, Inc.1991-07-17
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING (K911459)Fresenius USA, Inc.1991-07-17
NUTIP (TM) SYRINGE SHIELD (K911214)Western M/D, Inc.1991-07-17
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (K912150)Beckman Instruments, Inc.1991-07-17
TENDERFOOT(R), MODIFICATION (K911997)International Technidyne Corp.1991-07-17
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION (K911995)International Technidyne Corp.1991-07-17
ISE/CI- (K912647)Boehringer Mannheim Corp.1991-07-17
HEMOCHRON(R) APTT, MODIFICATION (K911994)International Technidyne Corp.1991-07-17
CARDIOCAP CMX-104 MONITOR (K903237)Datex Division Instrumentarium Corp.1991-07-17
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Every clearance here is in the API, with alerts when new ones post.