FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127921–127944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1990
PHARMACIA B2 MICRO EIA
K900449 · JZG
Pharmacia, Inc.
Immunology · 6d
Cleared Feb 02, 1990
ELECTRO-ACUSCOPE 85
K883911 · GZJ
Biomedical Design Instruments
Neurology · 505d
Cleared Feb 02, 1990
FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
K891289 · FRN
Baxter Healthcare Corp
General Hospital · 329d
Cleared Feb 02, 1990
FLEXIBLE IMMERSIBLE HYSTEROSCOPE
K892390 · HIH
Schott Fiber Optics, Inc.
Obstetrics & Gynecology · 301d
Cleared Feb 02, 1990
DADE(R) TDM CONTROL
K892642 · JJY
Baxter Healthcare Corp
Toxicology · 296d
Cleared Feb 02, 1990
PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT
K894403 · JWH
Howmedica Corp.
Orthopedic · 200d
Cleared Feb 02, 1990
BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
K894844 · DZE
Straumann Institute, Ltd.
Dental · 186d
Cleared Feb 02, 1990
MODEL 8100
K895629 · LNH
Medical Advances, Inc.
Radiology · 136d
Cleared Feb 02, 1990
WRIGHT VENTILOMETER VM-1
K895953 · BZG
Clement Clarke, Inc.
Anesthesiology · 114d
Cleared Feb 02, 1990
KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY
K896183 · GEX
Laserscope
General & Plastic Surgery · 100d
Cleared Feb 02, 1990
HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE
K896361 · EFB
Dentalez Group
Dental · 88d
Cleared Feb 02, 1990
ACS GOLD SERIES ELASTINITE GUIDE WIRE
K896379 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 88d
Cleared Feb 02, 1990
CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620
K896393 · DWC
Daily Medical, Inc.
Cardiovascular · 88d
Cleared Feb 02, 1990
MODEL: GYREX VERSION V
K896419 · LNH
Elscint, Inc.
Radiology · 86d
Cleared Feb 02, 1990
DOBBHOFF(R) ERCP CANNULA
K896518 · FGE
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 79d
Cleared Feb 02, 1990
DMV(R) VENEER SUCTION GRIPPER
K896565 · EKJ
Dmv Corp.
Dental · 77d
Cleared Feb 02, 1990
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
K896635 · GNW
Baxter Healthcare Corp
Microbiology · 72d
Cleared Feb 02, 1990
MF-450 ELECTROSURGICAL UNIT 60-5500-001
K896839 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 59d
Cleared Feb 02, 1990
BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
K900210 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 16d
Cleared Feb 02, 1990
ROMCHECK SPECIMEN COLLECTION KIT
K900225 · LIO
Adeza Biomedical
Microbiology · 16d
Cleared Feb 02, 1990
ET-RESTRAINT CAT. # ER 4000
K900236 · CBH
Ventlab Corp.
Anesthesiology · 16d
Cleared Feb 02, 1990
ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY
K900241 · LLL
Diamedix Corp.
Immunology · 16d
Cleared Feb 01, 1990
INTER-PAL C-19 AND INTER-PAL C-38
K890294 · JAQ
Enrad Corp.
Radiology · 378d
Cleared Feb 01, 1990
HEMOLASER HEMOSCOPE
K893816 · LYK
Hemolaser Corp.
Cardiovascular · 254d