FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
88849–88872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1998
DEGANIA SILICONE IDENTI LOOPS
K981956 · DXC
Degania Silicone , Ltd.
Cardiovascular · 35d
Cleared Jul 09, 1998
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES,...
K982032 · MEH
Osteonics Corp.
Orthopedic · 29d
Cleared Jul 09, 1998
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210 · LJC
Dade Behring, Inc.
Microbiology · 16d
Cleared Jul 09, 1998
VIGIL PROTEIN CONTROL
K982224 · JJY
Beckman Coulter, Inc.
Chemistry · 15d
Cleared Jul 08, 1998
SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS
K974698 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 204d
Cleared Jul 08, 1998
SKINTONER SYSTEM
K980501 · GEX
Fuller Research Corp.
General & Plastic Surgery · 149d
Cleared Jul 08, 1998
ODYSSEY INSTRUMENTATION SYSTEM
K981294 · FIZ
Automata Instrumentation, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 08, 1998
SPEED-CUT AUTOMATIC BIOPSY SYSTEM
K981301 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 90d
Cleared Jul 08, 1998
EBI DFS JOINT FIXATOR, MODEL 02800
K981483 · KTT
Electro-Biology, Inc.
Orthopedic · 75d
Cleared Jul 08, 1998
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY...
K981612 · EZL
Rochester Medical Corp.
Gastroenterology & Urology · 63d
Cleared Jul 08, 1998
KSEA UROPUMP
K981615 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 07, 1998
PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
K972255 · LOS
Pulse Biomedical, Inc.
Cardiovascular · 385d
Cleared Jul 07, 1998
PERCUTANEOUS BREAST BIOPSY (PBB)
K972328 · KNW
Urothealth System, Inc.
Gastroenterology & Urology · 379d
Cleared Jul 07, 1998
CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER
K972899 · DXQ
Cypress Medical Products, Ltd.
Cardiovascular · 335d
Cleared Jul 07, 1998
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
K974799 · JPA
International Technidyne Corp.
Hematology · 197d
Cleared Jul 07, 1998
SUGITRON MODEL: IEC
K980177 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 168d
Cleared Jul 07, 1998
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL)...
K980487 · KRH
Baxter Edwards
Cardiovascular · 148d
Cleared Jul 07, 1998
BIPOLAR FORCEPS SET (MODULAR)
K981321 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 88d
Cleared Jul 07, 1998
CUTALON NYLON POLYAMIDE SURGICAL SUTURE
K981322 · GAR
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 88d
Cleared Jul 07, 1998
ANU ICE
K981428 · LKX
Cryoptherapy Pain Relief Products, Inc.
Gastroenterology & Urology · 78d
Cleared Jul 07, 1998
IL TEST PT-FIBRINOGEN RECOMBINANT
K981479 · GJS
Instrumentation Laboratory CO
Hematology · 74d
Cleared Jul 07, 1998
GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION
K981488 · LYZ
Oak Carolina, Inc.
General Hospital · 71d
Cleared Jul 07, 1998
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY
K981559 · JZO
Pharmacia & Upjohn Co.
Immunology · 67d
Cleared Jul 07, 1998
ACS:CENTAUR AFP
K981592 · LOQ
Chiron Diagnostics Corp.
Immunology · 64d