Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SURGICAL DRAPE (K873313)American Medical Technology, Inc.1987-09-04
PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM (K872228)American Pharmaseal Div. Ahsc1987-09-04
FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (K870801)Travenol Laboratories, S.A.1987-09-04
TREACE MAGNUM OTO-TOOL SYSTEM (K873154)Treace Medical, Inc.1987-09-04
LASER CENTERING DEVICE (K872747)Innomed Corp.1987-09-04
BIOTROL ALPHA AMYLASE (K872831)Biotrol, USA, Inc.1987-09-04
HEARING AID (ALL-IN-THE-EAR) (K873001)Littlefield Co.1987-09-04
PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (K873097)Ipax, Inc.1987-09-04
VAN DELLEN RETROBULBAR NEEDLE (K873162)Van Dellen, Ltd.1987-09-04
INJECT-EASE (K872233)Palco Laboratories, Inc.1987-09-04
TRACH COLLAR (K872832)Rotek Corp.1987-09-04
UNIFAST GAMMA-GT (K873135)Sclavo, Inc.1987-09-04
AQUATULLE FINE MESH NON-ADHERING DRESSING (K872759)Smith & Nephew, Inc.1987-09-04
LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) (K863135)Neurotechnics, Inc.1987-09-04
VAN DELLEN IRRIGATING CYSTOTOME (K873163)Van Dellen, Ltd.1987-09-04
POREX OTOLOGY INSTRUMENTS (K873044)Porex Medical1987-09-04
IRRIGATION PRESSURE MONITOR (K872544)Avec Scientific Design Corp.1987-09-04
LOOK SPRING-ASSIST SYRINGES (K872944)Look, Inc.1987-09-04
MODEL K210 AND K211 FLUIDOTHERAPY UNITS (K871802)Henley Intl.1987-09-04
SAFETY SYRINGE (K872820)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-09-04
STRETCH GAUZE BANDAGES (K872875)Abco Dealers, Inc.1987-09-04
TROKEL SINGLE MIRROR YAG LASER LENS (K872802)Ocular Instruments, Inc.1987-09-04
ICOR NEONATAL HCH (K872371)Icor AB1987-09-04
SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM (K872590)Solco Basle, Inc.1987-09-04
MIC MUSHROOM TIP GASTROSTOMY TUBE (K872531)Medical Innovations Corp.1987-09-04
SPECTRO C (K872941)Ramco Laboratories, Inc.1987-09-04
WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 (K872327)Associated Mills, Inc.1987-09-04
VAN DELLEN HEALON CANNULA (K873164)Van Dellen, Ltd.1987-09-04
HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP) (K863136)Neurotechnics, Inc.1987-09-04
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT (K872394)Henley Intl.1987-09-03
LAKE CATHETER CARE KIT (K872750)Lake Medical Products, Inc.1987-09-03
CRT PORTABLE EMERGENCY OXYGEN INHALATOR (K872170)Cost Reduction Technologies, Inc.1987-09-03
SIEMENS O2-AIR MIXER 965 (K872278)Siemens Elema AB1987-09-03
ACROMED SCREW DRIVER (K873066)Buckman Co., Inc.1987-09-02
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM (K872390)Nichols Institute Diagnostics1987-09-02
QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) (K871903)Creative Scientific Technology, Inc.1987-09-02
CYBERFLUOR 615 IMMUNOANALYZER (K872803)Cyberfluor, Inc.1987-09-02
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT (K873310)Abbott Laboratories1987-09-02
DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT (K871328)E.I. Dupont DE Nemours & Co., Inc.1987-09-02
BIOTROL MAGNESIUM CALMAGITE (K873180)Biotrol, USA, Inc.1987-09-02
MULTI ANALYTE MIXTURES, CALIBRATORS (K873116)Biotrol, USA, Inc.1987-09-02
BIOTROL REFERENCE (K873118)Biotrol, USA, Inc.1987-09-02
ACROMED BONE SCREW TAP SLEEVES (K873067)Buckman Co., Inc.1987-09-02
PARAMAX URINE/CSF CALIBRATOR (K872789)American Dade1987-09-02
BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) (K872705)Clinical Technology Corp.1987-09-01
TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS (K873005)Techmedica, Inc.1987-09-01
CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 (K870804)American Bentley1987-09-01
THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS (K872085)Immunodiagnostics, Ltd.1987-09-01
KARYOTEC 100 (K872755)Amcor Electronics, Ltd.1987-09-01
ADJUSTABLE PEEP VALVE (K872202)Med Air Technology, Inc.1987-09-01
HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT (K871349)Howmedica Corp.1987-09-01
HOLTER ST SYSTEM, MODEL NO. 5000-20 (K871389)Holter Data Services1987-09-01
MICRO MAMMO I MAMMOGRAPHY UNIT (K871048)Amerasia Import-Export, Inc.1987-09-01
CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 (K872167)American Bentley1987-09-01
DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM (K872455)Adac Laboratories1987-09-01
GENE-TRAK CAMPYLOBACTER ASSAY (K863270)Integrated Genetics1987-08-31
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT (K873117)Biotrol, USA, Inc.1987-08-31
CURAD MEDICATED PLASTIC STRIPS (K872310)The Kendal Co.1987-08-28
ULTRASCAN IGE ASSAY KIT (K872968)Specialty Medical Industries, Inc.1987-08-28
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL (K873049)Boehringer Mannheim Corp.1987-08-28
IQ DIGOXIN (K864223)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-08-28
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR (K872107)Minntech Corp.1987-08-28
CAVROPUMP (K871129)Life-Tech Intl., Inc.1987-08-28
CEDIA DIGOXIN CR ASSAY (K872583)Microgenics Corp.1987-08-28
TECHNICON H*1 JR.(TM) SYSTEM (K873103)Technicon Instruments Corp.1987-08-28
ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER (K864849)Antek Instruments, Inc.1987-08-28
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 (K872321)Em Diagnostic Systems, Inc.1987-08-28
ANNULAR ARRAY SCANHEAD (K871856)Advanced Technology Laboratories, Inc.1987-08-28
MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET (K873109)Life-Tech Intl., Inc.1987-08-28
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST (K872114)Armkel, LLC1987-08-27
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER (K871110)Edward Weck, Inc.1987-08-27
MODEL 1858 CAVRO/PRESSURE MODULE (K872077)Life-Tech Intl., Inc.1987-08-27
MAM-CP X-RAY APPARATUS (K872980)Transworld X-Ray Corp.1987-08-27
BIOMET MODULAR SHOULDER PROSTHESIS (K872454)Biomet, Inc.1987-08-27
KODAK MIN-R MEDIUM SCREEN (K873167)Eastman Kodak Company1987-08-27
PROTHROMBIN TIME TEST (K872537)Sclavo, Inc.1987-08-27
KERR CAVALITE (K872147)Kerr Corporation (Danbury)1987-08-26
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM (K872785)Biotrol, USA, Inc.1987-08-26
CENTURION SPECIMEN TRAP W/CATHETER (K872141)Tri-State Hospital Supply Corp.1987-08-26
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM (K871846)Abbott Laboratories1987-08-26
BILE ACIDS REAGENT (K872296)Sigma Diagnostics, Inc.1987-08-26
OVONIC COATED SURGICAL SCISSORS (K873046)Micrins, Ltd.1987-08-26
INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR (K872647)Int'L Hearing Aids, Inc.1987-08-26
BIOPRO FEMORAL HIP COMPONENT (K872535)Biopro, Inc.1987-08-26
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL (K872777)Biotrol, USA, Inc.1987-08-26
ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST (K871601)Advanced Care Products1987-08-26
DISCIPLINE II RTD (K871557)Physio Systems, Inc.1987-08-26
OPHTHASONIC A-SCAN/ B-SCAN (K871536)Teknar, Inc.1987-08-26
ROTA-STAT (K864811)Intl. Diagnostic Laboratories, Ltd.1987-08-25
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY (K872131)Hybritech, Inc.1987-08-25
RPMI-1640 MEDIUM NO. R7755 AUTO-MOD(TM) W.O/L-GLU. (K873092)Sigma Chemical Co.1987-08-25
INFANT FEEDING TUBE (K872097)Tri-State Hospital Supply Corp.1987-08-25
(MEM) EAGLE NO. M7399 W/EARLE'S SALTS (K873094)Sigma Chemical Co.1987-08-25
ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. (K872630)Hgm, Inc.1987-08-25
MODIFIED INSTAFIL (K872446)Instafil, Inc.1987-08-25
CODMAN FLEXIBLE ENDOSCOPE (K871978)Codman & Shurtleff, Inc.1987-08-25
INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT (K872096)Tri-State Hospital Supply Corp.1987-08-25
CIBA CORNING 288 PH/BLOOD GAS SYSTEM (K872888)Ciba Corning Diagnostics Corp.1987-08-25
(MEM) EAGLE NO. M3149 W/HANKS' SALTS (K873095)Sigma Chemical Co.1987-08-25
MEDIUM 199 NO. M3274 W/HANKS' SALTS W.O/L-GLUTAMI. (K873090)Sigma Chemical Co.1987-08-25
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Every clearance here is in the API, with alerts when new ones post.