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
107521–107544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1994
ELECTRONIC THERMOMETERS
K940686 · FLL
American Diagnostic Corp.
General Hospital · 142d
Cleared Jul 08, 1994
SUNGLASSES
K941910 · HQY
The Orvis Co., Inc.
Ophthalmic · 80d
Cleared Jul 08, 1994
NON-FOGGING DENTAL MIRROR
K941954 · EKJ
Buffalo Dental Mfg. Co., Inc.
Dental · 77d
Cleared Jul 08, 1994
FACE-IT SHIELD
K942022 · LYU
Onyx Medical Corp.
General Hospital · 73d
Cleared Jul 08, 1994
GUARDIAN GLOVE
K942313 · LZC
Guardian Group, Inc.
General Hospital · 56d
Cleared Jul 08, 1994
NAVARRE PERCUTANEOUS ACCESS SET
K942315 · KGZ
Navarre Biomedical , Ltd.
General & Plastic Surgery · 56d
Cleared Jul 08, 1994
LASEAWAY Q-SWITCHED RUBY LASER SYSTEM
K942343 · GEX
Polytec Pi, Inc.
General & Plastic Surgery · 53d
Cleared Jul 08, 1994
PLAYTEX TAMPONS MODEL 13794
K942418 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 49d
Cleared Jul 08, 1994
CONSERVA POST SYSTEM
K942521 · ELR
Bull Frog Mfg. Co.
Dental · 43d
Cleared Jul 08, 1994
PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
K942583 · FTL
Bio-Vascular, Inc.
General & Plastic Surgery · 37d
Cleared Jul 08, 1994
LIFTING DISTENTION BALLOON SYSTEM
K942678 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 31d
Cleared Jul 08, 1994
EXTERNAL NASAL SPLINT
K942724 · EPP
Micromed Development Corp.
Ear, Nose, Throat · 29d
Cleared Jul 08, 1994
HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE
K942758 · LYY
Aladan Corp.
General Hospital · 25d
Cleared Jul 08, 1994
ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN
K942767 · EBF
Wallace A. Erickson & Co.
Dental · 25d
Cleared Jul 08, 1994
ELECTROSURGICAL LAPAROSCOPIC INSTRUMENT
K942915 · GEI
Morgan Medical Co.
General & Plastic Surgery · 17d
Cleared Jul 07, 1994
EVERT-O-CATH CATHETER
K922455 · DQO
American Biomaterials Corp.
Cardiovascular · 776d
Cleared Jul 07, 1994
LUNDIA ALPHA 700 HEMODIALYZER
K931720 · KDI
C.G.H. Medical, Inc.
Gastroenterology & Urology · 456d
Cleared Jul 07, 1994
SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
K932982 · HIS
Sime Health, Ltd.
Obstetrics & Gynecology · 384d
Cleared Jul 07, 1994
COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
K932983 · HIS
Sime Health, Ltd.
Obstetrics & Gynecology · 384d
Cleared Jul 07, 1994
UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI
K932984 · HIS
Sime Health, Ltd.
Obstetrics & Gynecology · 384d
Cleared Jul 07, 1994
3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE
K934333 · DRX
3M Medical Products Group
Cardiovascular · 303d
Cleared Jul 07, 1994
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
K935659 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 225d
Cleared Jul 07, 1994
DAIL A HEARING SCREENING TEST
K935719 · EWO
Occupational Hearing Services
Ear, Nose, Throat · 219d
Cleared Jul 07, 1994
STRATOFUSE PCA II INFUSER
K941151 · FRN
Infusion Technology Intl.
General Hospital · 118d