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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141529–141552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1986
RAPID SPECIFIC IGE PROCEDURE
K863394 · DHB
Allertec, Inc.
Immunology · 91d
Cleared Dec 03, 1986
SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG
K863428 · LNK
Laser Media
Gastroenterology & Urology · 90d
Cleared Dec 03, 1986
VIBRATRON II, VIBRATION SENSITIVITY TESTER
K863607 · LLN
Sensortek, Inc.
Neurology · 78d
Cleared Dec 03, 1986
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642 · FFK
Candela Corp.
Gastroenterology & Urology · 77d
Cleared Dec 03, 1986
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · LJP
Kallestad Laboratories, Inc.
Microbiology · 75d
Cleared Dec 03, 1986
3M IGG4 FAST TEST PACKAGE
K863794 · DHB
3M Company
Immunology · 68d
Cleared Dec 03, 1986
UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
K864142 · DGC
United Biotech, Inc.
Immunology · 42d
Cleared Dec 03, 1986
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K864207 · KTN
Gamma Biologicals, Inc.
Immunology · 37d
Cleared Dec 03, 1986
MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT
K864329 · KNW
Dlp, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 03, 1986
SEMINAL FLUID COLLECTION KIT(TM)
K864473 · HIS
Apex Technologies, Inc.
Obstetrics & Gynecology · 20d
Cleared Dec 02, 1986
IDEX DENTAL IMPLANT
K862177 · DZE
R. J. Chapman, D.M.D.
Dental · 176d
Cleared Dec 02, 1986
SENTINEL 4 EEG ANALYZER
K863193 · GWQ
Axon Systems, Inc.
Neurology · 105d
Cleared Dec 02, 1986
MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME
K863805 · JWH
Zimmer, Inc.
Orthopedic · 63d
Cleared Dec 02, 1986
TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
K863935 · JAK
Toshiba Medical Systems
Radiology · 54d
Cleared Dec 02, 1986
EMPI MODEL 712, LOGIX(TM), NMS
K864010 · IPF
Empi
Physical Medicine · 48d
Cleared Dec 02, 1986
KNEECPM
K864427 · BXB
Invacare Corp.
Physical Medicine · 20d
Cleared Dec 02, 1986
FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000
K864477
Foundations Plus, Inc.
General & Plastic Surgery · 19d
Cleared Dec 01, 1986
HYDROPHILIC REPROSIL
K863288 · ELW
Dentsply Intl.
Dental · 98d
Cleared Dec 01, 1986
HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER
K863750 · LJT
C.R. Bard, Inc.
General Hospital · 67d
Cleared Dec 01, 1986
VISCOPASTE ZINC PASTE BANDAGE
K863930 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 54d
Cleared Dec 01, 1986
CARBONET ODOUR ADSORBING DRESSING
K863931
Smith & Nephew, Inc.
General & Plastic Surgery · 54d
Cleared Dec 01, 1986
ELM ALLERGEN DISC
K863973 · DHB
Immuno Nuclear Corp.
Immunology · 48d
Cleared Dec 01, 1986
MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR
K864289 · KCW
Alexander Thomas, Inc.
General & Plastic Surgery · 31d
Cleared Dec 01, 1986
MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX
K864342 · CFN
Eiken Chemical Co., Inc.
Immunology · 27d