Atlas FDA

1986

4,347 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY (K854945)Ciba Corning Diagnostics Corp.1986-02-11
SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS (K860074)Warsaw Orthopedic, Inc.1986-02-11
CPK REAGENT SET (COLORIMETRIC) (K860096)Sterling Diagnostics, Inc.1986-02-11
GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD (K855203)Miles Laboratories, Inc.1986-02-11
CREATININE REAGENT SET (K860418)Sterling Diagnostics, Inc.1986-02-11
PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG (K854469)Minnesota Laser Corp.1986-02-11
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA (K860252)Amersham Corp.1986-02-11
AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA (K860251)Amersham Corp.1986-02-11
METRICOM (K860225)Far Orthopedics, Inc.1986-02-11
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY (K860421)American Dade1986-02-11
VENOUS RETURN CANNULA W/CUFF 91039 (K854487)Dlp, Inc.1986-02-10
MA-1 VOLUME VENTIALTOR (K854843)Puritan Bennett Corp.1986-02-10
ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET (K854511)Electro-Catheter Corp.1986-02-10
SHILEY VENOUS RESERVOIR (K854841)Shiley, Inc.1986-02-10
TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 (K854406)Tecan U.S., Ltd.1986-02-10
DEMAND FLOW VALVE & SONRA W/NASAL MASK (K854571)Gale E. Dryden1986-02-10
STUART GILMAN'S WEIGHT LOSS PLAN (K854441)Alpha Therapeutic Corp.1986-02-10
DISPOSABLE MANIFOLD (K854960)Utah Medical Products, Inc.1986-02-10
MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE (K854734)Medasonics, Inc.1986-02-10
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732 (K855003)Travenol Laboratories, S.A.1986-02-10
CURITY URETERAL STENT (K854862)The Kendal Co.1986-02-10
MODIFIED CORONARY CARDIOPLEGIA ADAPTOR (K854640)Shiley, Inc.1986-02-10
LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM (K854465)Link America, Inc.1986-02-10
HYDRAJUST III UROLOGICAL TABLE (K860040)Mallinckrodt Group, Inc.1986-02-10
URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE (K860143)Reagent Laboratory, Inc.1986-02-10
ANGIOMED URETERAL STONE DISLODGERS (K854652)Angiomed U.S., Inc.1986-02-10
VIT PAC (K834162)American Surgical Co., Inc.1986-02-07
NIDEK AC-2000 LASER SYSTEM (K860011)Nidek, Inc.1986-02-07
CODMAN LASER BACKSTOP (K853626)Codman & Shurtleff, Inc.1986-02-07
ACROMED CANCELLOUS BONE SCREW (K860017)Buckman Co., Inc.1986-02-07
VISITHERM (K852950)C.D. Regelin & Associates, Inc.1986-02-07
VITREONIC PLUS (K834160)American Surgical Co., Inc.1986-02-07
MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM (K854387)Directed Energy, Inc.1986-02-07
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA (K854506)Storz Instrument Co.1986-02-07
VIS-2000 VIDEO SYSTEM (K860173)Vistek Corp.1986-02-07
MICRO SURGICAL SYSTEM (K854871)Mira, Inc.1986-02-07
SLUSH PAN COVER (K860065)O.R. Concepts, Inc.1986-02-07
I/A - VFE SYSTEM II (K854868)Mira, Inc.1986-02-07
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS (K854507)Storz Instrument Co.1986-02-07
WINK-EASE DISPOSABLE PROTECTIVE (K860043)Eye Pro Medical Products, Inc.1986-02-07
FISCHER WIRE/PIN CLAMP (K860018)Buckman Co., Inc.1986-02-07
ACUSON NEEDLE GUIDE SYSTEM (K854429)Acuson Computed Sonography1986-02-07
MODEL 20-B CO2 LASER SYSTEM (K854399)Directed Energy, Inc.1986-02-07
5.0 IOP & 7.5 IOP PROBES (K853432)Diasonics, Inc.1986-02-07
CODMAN LASER RODS (K853627)Codman & Shurtleff, Inc.1986-02-07
FIBEROPTIC COLLIMATING HANDPIECE (K854134)Dawn Laser Technology, Inc.1986-02-07
PRECIOUS LITE MODEL 4224 (K854122)E & B Technologies, Inc.1986-02-07
KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) (K853727)Ryder Intl. Corp.1986-02-07
CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS (K853420)Alvar1986-02-07
PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI (K854470)Minnesota Laser Corp.1986-02-07
MODEL CO2 LASER SYSTEM 8B (K854398)Directed Energy, Inc.1986-02-07
T3 UPTAKE RADIOIMMUNOASSAY KIT (K855169)Cambridge Medical Technology1986-02-06
TABLE RADIOGRAPHIC FIXED (K855052)X-Ray Systems1986-02-06
DAISY (ABSORBENT INCONTINENCE SHIELD) (K854730)Lic-Orthion1986-02-06
LDH (OPTIMIZED) REAGENT (K860029)Sigma Chemical Co.1986-02-06
THE BLEDSOE PASSIVE MOTION EXERCISER (K854354)Medical Technology and Innovations, Inc.1986-02-06
ADAM (ABSORBENT INCONTINENCE SHIELD) (K854729)Lic-Orthion1986-02-06
EIA PROCESSOR (K854936)Abbott Laboratories1986-02-06
QWIK-CALL (K860052)Emde Corp.1986-02-06
BUN (ENZYMATIC BERTHELOT) REAGENT SET (K860154)Sterling Diagnostics, Inc.1986-02-06
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT (K860134)Em Diagnostic Systems, Inc.1986-02-06
MEVASSIST(SETUP CONTROLLER) (K852609)Magus Microcontrollers, Inc.1986-02-06
POWERED TRACTION EQUIPMENT (K860227)R. P. Hood, Inc.1986-02-06
THUMPER (VIBRATOR/MASSAGER) (K860159)Wellness Innovations Corp.1986-02-06
V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT (K854971)V-Tech, Inc.1986-02-06
ENZYMATIC UREA NITROGEN REAGENT SET (K860109)Technostics Intl.1986-02-06
RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE (K860301)Carr-Scarborough Microbiologicals, Inc.1986-02-06
CARDIMAX FX-1164 (K853979)Brentwood Instruments, Inc.1986-02-06
DIESSE RF TEST KIT (K854222)Marvic Interpharma, Inc.1986-02-06
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. (K860140)American Dade1986-02-06
PYR DISCS (K860302)Carr-Scarborough Microbiologicals, Inc.1986-02-05
INFANT BODY TEST (K853390)Erich Jaeger, Inc.1986-02-05
CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS (K860293)Difco Laboratories, Inc.1986-02-05
RPMI 1640 W/GLUTAMINE W/HEPES (K860282)Newport Biosystems, Inc.1986-02-05
PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) (K854577)Austin Biological Laboratories1986-02-05
ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM (K860063)Laser Media1986-02-05
MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM (K855205)Hana Biologics, Inc.1986-02-05
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 (K854666)Clinical Sciences, Inc.1986-02-05
TECHNICON H*1 SYSTEM (MPXI) (K853027)Technicon Instruments Corp.1986-02-05
SPIROMETER, MODEL TS-500 PART #SLZ7534 (K855068)Teledyne Avionics Div. of Teledyne1986-02-05
JMS AV FISTULA NEEDLE (K860241)Jms Co., Ltd.1986-02-05
HEMOR-ICE (K854569)Technology 20001986-02-05
CAPD TRANSFER SET SPIKE 5C4363 (K860230)Travenol Laboratories, S.A.1986-02-05
HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD (K852955)Renalchem, Inc.1986-02-05
RX02 PLUS OXYGEN CONCENTRATOR (K860060)The John Bunn Co.1986-02-05
ERGO-PNEUMOTEST (K853434)Erich Jaeger, Inc.1986-02-05
TOURIQUET KIT WITH SNARE (K855144)Dlp, Inc.1986-02-05
TECHNICON H*1 SYSTEM (HDW) (K853030)Technicon Instruments Corp.1986-02-05
CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000 (K860292)Difco Laboratories, Inc.1986-02-05
INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT (K853484)Biotech Research Laboratories, Inc.1986-02-05
MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY (K860152)Endo Lase, Inc.1986-02-05
SCREENMATE (K853409)Erich Jaeger, Inc.1986-02-05
BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) (K860056)Berkowits School of Electrolysis, Inc.1986-02-05
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (K854851)Wellcome Diagnostics1986-02-04
SUNGLASSES (K854818)Jarnger Trading Co., Ltd.1986-02-04
ASSERACHROM FPA KIT (K854384)American Bioproducts Co.1986-02-04
INSTA-GLAZE (K854588)George Taub Products & Fusion Co., Inc.1986-02-04
FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (K853540)Idt, A Division of Whittaker M.A. Bioproducts1986-02-04
FASCILULATED NAIL (K854227)The Deca Co.1986-02-04
CYTOMEGELISA M TEST KIT (K854839)Whittaker Bioproducts, Inc.1986-02-04
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Every clearance here is in the API, with alerts when new ones post.