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
148897–148920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1985
ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
K844765 · EWQ
Laser Spectrum, Inc.
Ear, Nose, Throat · 122d
Cleared Apr 08, 1985
POST-AURICULAR HEARING AID MODEL PE 600PPCH
K844862 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 115d
Cleared Apr 08, 1985
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
K850013 · IPF
Mettler Electronics Corp.
Physical Medicine · 96d
Cleared Apr 08, 1985
BACI 6 -ADRENOCORTICOTROOP HORMONE
K850053 · CKG
Euro-Diagnostics BV
Chemistry · 90d
Cleared Apr 08, 1985
LUNE AU CURETTES
K850068 · HCY
Luneau Laboratories
Obstetrics & Gynecology · 90d
Cleared Apr 08, 1985
CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES
K850256 · GTZ
Abbott Laboratories
Microbiology · 76d
Cleared Apr 08, 1985
MICROSURGERY VISIBILITY BACKGROUND MATERIAL
K850375
Ethicon, Inc.
General & Plastic Surgery · 67d
Cleared Apr 08, 1985
ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM
K850509 · LNK
Laser Media
Gastroenterology & Urology · 59d
Cleared Apr 08, 1985
PRECO PREGNANCY RAPID CARD TEST, HEM #2028
K850604 · JHJ
Preco, Inc.
Chemistry · 52d
Cleared Apr 08, 1985
MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE
K850728 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 45d
Cleared Apr 08, 1985
CERESTORE DENTIN PORCELAIN
K850821 · EIH
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared Apr 08, 1985
PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST
K850824 · EBF
Kuraray Co.
Dental · 39d
Cleared Apr 08, 1985
STREP A QUICK
K850831 · GTZ
Abbott Laboratories
Microbiology · 38d
Cleared Apr 08, 1985
DATA ZYME CO2 PROCEDURE
K850903 · KHS
Data Medical Associates, Inc.
Chemistry · 34d
Cleared Apr 08, 1985
MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM
K850987 · JHI
Medix Biotech, Inc.
Chemistry · 28d
Cleared Apr 08, 1985
TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN
K850999 · JJF
Technicon Instruments Corp.
Chemistry · 28d
Cleared Apr 08, 1985
GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS.
K851110 · HFB
The Huxley Instrument Corp.
Obstetrics & Gynecology · 20d
Cleared Apr 08, 1985
EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153
K851207 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 13d
Cleared Apr 08, 1985
COMPACT EXCHANGE DEVICE 5C4197
K851208 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 13d
Cleared Apr 05, 1985
AUDIT TM V
K843712 · GWF
Axonics, Inc.
Neurology · 196d
Cleared Apr 05, 1985
CYBERTENS
K844680 · GZJ
Pori Associates, Inc.
Neurology · 126d
Cleared Apr 05, 1985
AEQUITRON MED-7100 PHOTOTHERAPY LIGHT
K850181 · LBI
Aequitron Medical, Inc.
General Hospital · 77d
Cleared Apr 05, 1985
AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE
K850265 · CAH
American Pharmaseal Div. Ahsc
General Hospital · 72d
Cleared Apr 05, 1985
TEMPALERT LIQUID CRYSTAL THERMOMETER
K850797 · KPD
Medical Frontiers, Inc.
General Hospital · 37d