Atlas FDA

1987

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

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RecordFirmDate
KM-4(TM) METAL-BACKED ACETABULAR CUP (K870867)Kirschner Medical Corp.1987-05-08
COMPASS STEREOTACTIC POSITIONING SYSTEM (K871046)Stereotactic Medical Systems, Inc.1987-05-08
CSI/3D (K870513)Columbia Scientific, Inc.1987-05-08
GRATICULE (K871214)Mick Radio-Nuclear Instruments, Inc.1987-05-08
IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR (K871664)Instrumentation Laboratory CO1987-05-08
(FPIA) ASSAY BUFFER (K871486)Windsor Laboratories, Inc.1987-05-08
PERSONNEL PROTECTIVE SHIELD (K871502)Cis-Us, Inc.1987-05-08
SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 (K871189)Sunbeam Appliance Service Co.1987-05-08
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) (K871509)Trace Scientific , Ltd.1987-05-08
A1-A2 AMBULATORY EEG CASSETTE RECORDER (K870432)Grass-Telefactor Product Group1987-05-08
PREFILLED STERILE WATER FOR INHALATION, USP (K871618)Automatic Liquid Packaging, Inc.1987-05-08
TRACH MATE TRACHEAL TUBE (K870470)Mccormick Laboratories, Inc.1987-05-08
EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE (K870387)American Pharmaseal Div. Ahsc1987-05-08
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST (K870602)Boots-Celltech Diagnostics, Inc.1987-05-08
RODRIGUEZ NAIL (K871608)Richards Medical Co., Inc.1987-05-08
SERVO NEBULIZER 945 SIEMENS-ELEMA AB (K871293)Siemens Elema AB1987-05-08
DAHLBERG MODEL UH IN-THE-EAR HEARING AID (K871524)Dahlberg Electronics, Inc.1987-05-08
SURGICAL CAMERA ACCESSORIES (K871595)M.P. Video, Inc.1987-05-07
LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1 (K871245)Chiron Vision Corp.1987-05-07
SITE PERISTALTIC MODULE SYSTEM (K871375)Site Microsurgical Systems, Inc.1987-05-07
CPU-1 INTENSIVE CARE VENTILATOR (K871398)Ohmeda Medical1987-05-07
HEATED INSTRUMENT BATH (K870276)Simpson/Basye, Inc.1987-05-07
SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS (K871478)Procedure Pak, Inc.1987-05-07
NAMIC COURNAND STYLE INTRODUCER NEEDLE (K871377)North American Instrument Corp.1987-05-07
MINGOGRAF 740 - MODEL #91-54-634 (K864575)Siemens Medical Solutions USA, Inc.1987-05-07
NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT (K870187)Norfolk Medical Products, Inc.1987-05-07
CARIESCREEN LB (K871264)Apo Diagnostics, Inc.1987-05-07
CLEANING SOLUTION, CATALOG NO. 8203 (K870759)Treace Medical, Inc.1987-05-07
MODEL 105 VENTILATOR (K871448)Developmed Corp.1987-05-07
KRATZ NOVA-SERT (K871440)CooperVision, Inc.1987-05-07
AMERICAN ALCOHOL PREP PAD STERILE MEDIUM (K870718)Span-America Medical Systems, Inc.1987-05-07
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST (K871196)Orion Diagnostica, Inc.1987-05-06
IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM (K870934)Integrated Medical Systems, Inc.1987-05-06
ONGUARD 1000, CATALOG #043611-000 & 043611-001 (K870976)Cobe Laboratories, Inc.1987-05-06
NAMIC ONE PART INTRODUCER NEEDLE (K871382)North American Instrument Corp.1987-05-06
PELTIERTHERAPY(C) HEAT/COLD TREATMENT (K871112)Henley Intl.1987-05-06
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR (K870829)3M Health Care, Sarns1987-05-06
MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR (K870981)Everest Medical Corp.1987-05-06
PRECIMAT(R) CRP (K871055)Boehringer Mannheim Corp.1987-05-06
THE KEEPER (K870803)The Keeper Co.1987-05-06
OVU-TRAC OVULATION TIMING KIT (K870528)Ob/Gyn Concepts, Ltd.1987-05-06
UPPERCYCLE STATIONARY EXERCISE MACHINES (K871494)Engineering Dynamics Corp.1987-05-06
CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II (K871537)Canyon Diagnostics, Inc.1987-05-06
LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER (K870886)Strato Medical Corp.1987-05-06
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 (K871438)Fraass Survival Systems, Inc.1987-05-06
FOLDING LITTER SUPPORT, NSN6530-00-660-0034 (K871629)Junkin Safety Appliance Co., Inc.1987-05-06
AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) (K871391)Amigo Sales, Inc.1987-05-06
DISPOSABLE PERIODONTAL PROBE (K871504)Periodontal Health Brush, Inc.1987-05-06
IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL (K871333)Medtronic Vascular1987-05-06
MVP-1500 CONTINUOUS VENTILATOR (K871009)Medimex, Inc.1987-05-06
ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD (K864690)Multi Biosensors, Inc.1987-05-06
MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER (K870301)Medex, Inc.1987-05-06
NAMIC SELDINGER INTRODUCER NEEDLE (K871378)North American Instrument Corp.1987-05-06
CORDAY CORONARY SINUS INFUSION CATHETER (K865074)Retroperfusion Systems, Inc.1987-05-06
PATIENT MOVER(TM) (K871582)T.B.S., Inc.1987-05-06
VASOPULSE(TM)/MODEL 5000 (K863803)Sonicaid, Inc.1987-05-06
AMBULATORY INFUSION PUMP DRUG RESERVOIR (K870524)Med Fusion Systems, Inc.1987-05-06
CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 (K864456)Cala Diagnostics1987-05-06
BONE PLATE (K870082)Terray Manufacturing, Inc.1987-05-06
INVIVO PULSE OXIMETER, MODEL 4500 (K864730)Invivo Research Labs, Inc.1987-05-06
AM1000 (K864590)Bear Medical Systems, Inc.1987-05-04
NO. 1552, VALVED VENTI-COMP (K870895)Hudson Oxygen Therapy Sales Co.1987-05-04
FIAD EXPLOR-X; MODEL 70 KVP (K871051)United States Dental1987-05-04
PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085 (K870692)Peritronics Research and Development, Inc.1987-05-04
WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM (K870830)Warsaw Orthopedic, Inc.1987-05-04
MODIFIED C.P.R. MICROSHIELD (K871403)Westmark Enterprises, Inc.1987-05-04
PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE (K870797)Safco Dental Supply1987-05-01
DTV-4112 FLUOROSCOPIC TELEVISION CAMERA (K871127)Adac Laboratories1987-05-01
CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE (K870403)Burron Medical Products, Inc.1987-05-01
SCHELL C.A.P.P. BED MODEL NRS. 1268 + 1269 (K871368)Schell B.V.1987-05-01
STD-228 SPECTRAL TREND DISPLAY (K871480)Grass-Telefactor Product Group1987-05-01
DTV-411OP (K870869)Adac Laboratories1987-05-01
ARTHROSCOPIC MENISCAL SUTURE SYSTEM (K871323)Orthopedic Systems, Inc.1987-05-01
M10 EEG MONITOR SCOPE (K871120)Telediagnostic Systems, Inc.1987-05-01
JOHNSON & JOHNSON STAINING REMOVING COMPOUND (K864226)Johnson & Johnson Professionals, Inc.1987-05-01
IVT SOUTHWEST ALLERGY SCREEN (K870625)In Vitro Technologies, Inc.1987-05-01
STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP (K870699)Depuy, Inc.1987-05-01
H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS (K870660)Holter-Hausner Intl.1987-05-01
FRESENIUS HEMOFLOW F6 AND F8 (K870725)Seratronics, Inc.1987-05-01
SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE (K870793)Self Regulation Systems, Inc.1987-05-01
AM CATH ESWL STENT (K871291)Inter-Med Corp.1987-04-30
MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER (K871464)Medgroup Enterprises, Inc.1987-04-30
ALGINATE WOOL FIBER (K870383)Adri1987-04-30
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT (K871218)Hospal Medical Corp.1987-04-30
SWIVEL CONNECTORS #014452/#014453/#014459-120 (K871540)Clinical Connections, Inc.1987-04-30
DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE (K871154)Delmed, Inc.1987-04-30
MERIVAARA EMERGENCY PATIENT TROLLEY #436 (K871556)Global Medical Prods, Inc.1987-04-30
ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE (K871007)Habley Medical Technology Corp.1987-04-30
ULTRA-VIOLET GLUCOSE REAGENT KIT (K871456)Biochemical Trade, Inc.1987-04-29
TANGENT SYSTEM(TM) ANA PROFILE TEST KIT (K871144)Vitrotec Laboratories, Inc.1987-04-29
TOMTEC GRAM STAINER DECOLORIZER (K871533)Remel Co.1987-04-29
10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE (K871360)Quinton, Inc.1987-04-29
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 (K870958)Helena Laboratories1987-04-29
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST (K870946)Serono Diagnostics, Inc.1987-04-29
METHYL GREEN SOLUTION (K871544)Sigma Diagnostics, Inc.1987-04-29
NEUTRAL RED (K871477)Sigma Chemical Co.1987-04-29
MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 (K871541)Gibco Laboratories Life Technologies, Inc.1987-04-29
TITAN GEL IMMUNOFIX CONTROLS (K871498)Helena Laboratories1987-04-29
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (K864128)Diagnostic Technology, Inc.1987-04-29
CHLAMYDIAZYME DIAGNOSTIC KIT (K864842)Abbott Laboratories1987-04-29
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Track 1987 automatically

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