Atlas FDA

1986

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

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RecordFirmDate
PATIENT MONITOR PB240 (K853318)Puritan Bennett Corp.1986-03-11
ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY (K855142)Angiomed U.S., Inc.1986-03-11
MENTOR CORPORAL DILATORS (K860517)Mentor Corp.1986-03-11
HARD CONTACT LENS CLEANING & SOAKING SOLUTION (K853808)Maurry Biological Co.1986-03-11
NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. (K854720)Nemectron Medical, Inc.1986-03-10
HARBOR MEDICAL RESPIRATORY TRAY (K860506)Harbor Medical, Inc.1986-03-10
DIMENSION TOTAL HIP PROSTHESIS POROUS COATED (K854107)Kirschner Medical Corp.1986-03-10
SOLAR F (K854641)Alpine Dental Equipment Co.1986-03-10
C ARM SURGICAL TABLE (K860446)Medi-Mech, Inc.1986-03-10
SONOLINE SX ULTRASOUND SCANNER (K852739)Siemens Medical Solutions USA, Inc.1986-03-10
OCULAB BIOMETRICPEN (K860061)Oculab, Inc.1986-03-10
STANDARD WHEELCHAIRS (K860521)Formotion, Inc.1986-03-10
XISCAN MODEL 1000 (K852346)Xi Tech1986-03-10
INLAY WAX REGULAR (K854529)The Hygenic Corp.1986-03-10
OCULAB PACHPEN (K860062)Oculab, Inc.1986-03-10
BILE ENDOPROSTHESIS SET (K860534)Angiomed U.S., Inc.1986-03-10
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU (K860133)Depuy, Inc.1986-03-10
GAMMA-FREE HORSE SERUM (K860762)Flow Laboratories, Inc.1986-03-10
SONOLINE CD (K852686)Siemens Medical Solutions USA, Inc.1986-03-10
CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT (K860179)Difco Laboratories, Inc.1986-03-10
HARBOR MEDICAL DRESSING TRAY (K860507)Harbor Medical, Inc.1986-03-10
GOAT SERUM (29-391-54) (K860752)Flow Laboratories, Inc.1986-03-10
PSEUDOMONAS AGAR P (MEDIUM A) (K860750)Gibco Laboratories Life Technologies, Inc.1986-03-10
DIGIRAD REUSABLE IMAGE MEDIA (K854407)Digirad Corp.1986-03-10
MAXIMUS CUSHION (K855072)Jay Medical, Ltd.1986-03-10
ACE MULTIPLE PIN PLATE (K860591)Buckman Co., Inc.1986-03-10
ISOSTATION KNEE MACHINE (K-100) (K854621)Isotechnologies, Inc.1986-03-07
PHOENIX MODELS 250/251 PULSE GENERATORS (K855081)Pacesetter Systems1986-03-07
HSV IDR (K854974)Genus Diagnostics1986-03-07
ACE UNILATERAL FIXATOR (K860590)Buckman Co., Inc.1986-03-07
8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR (K860158)Neuromed, Inc.1986-03-07
CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES. (K854964)Deltec Systems, Inc.1986-03-07
ISO-MAMMO (K860129)Philips Medical Systems (Cleveland), Inc.1986-03-06
SPARTAN SOLDER (K854738)Williams Gold Refining Co., Inc.1986-03-06
SWEET DREEMS SIMULATOR (K860596)Sweet Dreams, Inc.1986-03-06
FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE (K855136)Union Broach, Div. Moyco Industries, Inc.1986-03-06
KODAK X-OMAT PROCESSOR, MODEL ME-3 (K860666)Eastman Kodak Company1986-03-06
NEMECTRODYN MODEL 2 & ENDOVAC 2 (K854721)Nemectron Medical, Inc.1986-03-06
PLASTIC MOUNTING RINGS (K854702)Almore Intl., Inc.1986-03-06
API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) (K854733)Dms Products, Inc.1986-03-06
DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS (K855112)Pacific Union Dental, Inc.1986-03-06
VEGA DENTAL OPERATING LIGHT (K854646)Alpine Dental Equipment Co.1986-03-06
TEC 2720 MAMEX DC MAG (K854203)Tecnomed, Inc.1986-03-06
TRU-COLOR (K855037)Veritas Dental Co., Inc.1986-03-06
DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES (K855111)Pacific Union Dental, Inc.1986-03-06
KODAK T-MAT M FILM SO-245 (K860754)Eastman Kodak Company1986-03-06
TUBING HANDPIECE REPLACEMENT (K854697)Almore Intl., Inc.1986-03-06
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK (K860031)Organon Teknika Corp.1986-03-06
FS TEST KIT (K854015)American Bioproducts Co.1986-03-06
X-RANGE 65 (K854741)Alpine Dental Equipment Co.1986-03-06
IMIPENEM SUSCEPTIBILITY POWDER (K855071)Merck, Sharp & Dohme1986-03-06
FLOSS HOLDER (PLASTIC) (K855113)Pacific Union Dental, Inc.1986-03-06
KODAK MIN-R FAST SCREEN SO-459 (K860755)Eastman Kodak Company1986-03-06
RETRACT-A-CORD (K854701)Almore Intl., Inc.1986-03-06
KEITHLEY MODEL 75100 & 75200 (K854110)Keithley Instruments, Inc.1986-03-06
BT-795/P AUTOMATED AUTOTRANS (K860306)Electromedics, Inc.1986-03-06
STARTANIUS DENTAL IMPLANT SYSTEM (K854749)Park Dental Research Corp.1986-03-06
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 (K855106)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-03-06
KULTSURE (CATALOGUE NO. M200) (K860655)Ncs Diagnostics, Inc.1986-03-06
IMIPENEM 10 MCG SENSITIVITY DISCS (K855207)Difco Laboratories, Inc.1986-03-06
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR (K860180)Life Support Products, Inc.1986-03-06
ELLIK EVACUATOR (K860266)R. J. Ltd., Ind.1986-03-05
MARKOPTIC IMPROVED ARTHROSCOPE (K860607)Markoptic1986-03-05
STORZ E9040 & E9046 DIAMOND KNIVES (K855050)Storz Instrument Co.1986-03-05
LINK METAL-BACKED ACETABULAR CUPS (K854935)Link America, Inc.1986-03-05
INTRAOCULAR FORCEPS & SCISSORS (K854869)Mira, Inc.1986-03-05
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 (K855079)Em Diagnostic Systems, Inc.1986-03-05
MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY (K860490)Medix Biotech, Inc.1986-03-05
ABL330 ACID BASE LABORATORY (K860057)Radiometer America, Inc.1986-03-05
CPK (UV) REAGENT KIT (K855188)Technostics Intl.1986-03-05
IL TEST PHENYTOIN (K860286)Allied Instrumentation Laboratory1986-03-05
NORDIC SUN HOME TANNING UNIT (K860567)Nordic Sun Corporation of America1986-03-05
SYSTEMS PLUS (K860014)United Surgical Corp.1986-03-05
SUNBED/CANOPY, MODELS GTI 24N,30R,30RE & 37RE (K860509)Ecomatic GmbH, Frankfurt, F.R.G.1986-03-05
MONOFIXATEUR (K854336)Ortopedia GmbH1986-03-05
ACID PHOSPHATASE REAGENT SET (K860476)Sterling Diagnostics, Inc.1986-03-05
NORDIC SUN 24 LAMP TANNING BED (K860566)Nordic Sun Corporation of America1986-03-05
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT (K860542)Hybritech, Inc.1986-03-05
MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS (K860598)Procter & Gamble Mfg. Co.1986-03-05
ENCORE PROLACTIN REAGENT (K860221)Hybritech, Inc.1986-03-05
CASTLE 7538 FLOOR LOADING WASHER (K860263)Castle Co.1986-03-05
SKD ELECTROCHEMICAL SYSTEM (ECS) (K854723)Smithkline Diagnostics, Inc.1986-03-05
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS (K860336)Breem Laboratories1986-03-04
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER (K854835)Miracle-Ear/Dahlberg, Inc.1986-03-04
HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER (K854795)Fran Hazelton Co.1986-03-04
API 50 CHB (CULTURE MEDIA) (K854732)Dms Products, Inc.1986-03-04
3M ARTHROSCOPIC SURGICAL SYSTEM (K855216)3M Company1986-03-04
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT (K853009)Roche Diagnostic Systems, Inc.1986-03-04
ROTALEX (K860529)Orion Corp.1986-03-04
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES (K860297)Renal Hygienics1986-03-04
NEG COMBO BREAKPOINT PANEL POS COMBO (K854278)American Micro Scan1986-03-04
SPIRAL-FLEX (K860105)Sheridan Catheter Corp.1986-03-04
DUAL LUMEN NEEDLE (PRODUCT CHANGE) (K860515)Quinton, Inc.1986-03-04
TBI NEEDLE (K860582)Hobbs Medical, Inc.1986-03-04
TRACHEOSTOMY CARE KIT (K855130)Dynarex Corp.1986-03-04
DYNA SYSTEM (K855167)Parker Laboratories, Inc.1986-03-04
DAHLBERG MODEL KC IN-THE-EAR HEARING AID (K854834)Miracle-Ear/Dahlberg, Inc.1986-03-04
INSTA KIT FOR GROUP A STREP ID (K860247)Mead Johnson & Co.1986-03-04
KULTSURE (CATALOGUE NO. M240) (K860657)Ncs Diagnostics, Inc.1986-03-04
CHAMELEON BONDING KIT (K854803)Pentron Corp.1986-03-04
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Every clearance here is in the API, with alerts when new ones post.