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
126313–126336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1990
GS-4350 TROCAR ONLY, 5.5MM
K900963 · FBM
Solos Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 18, 1990
CANNULA AND TROCAR, 11MM
K900964 · FBM
Solos Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 18, 1990
GS-4550 TROCAR ONLY, 11MM
K900965 · FBM
Solos Endoscopy, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 18, 1990
LATEX EXAMINATION GLOVES
K901213 · LYY
United Orient, Inc.
General Hospital · 35d
Cleared Apr 18, 1990
ARTHROSCOPIC ELECTROSURGICAL PROBE
K901505 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 19d
Cleared Apr 18, 1990
AUDIOTONE MODEL FFI ITE HEARING AID
K901556 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 18, 1990
BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
K901569 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 14d
Cleared Apr 17, 1990
LIFE-LINE(TM) VASCULAR ACCESS SYSTEM
K895030 · LJT
Medical Engineering and Development...
General Hospital · 252d
Cleared Apr 17, 1990
GESCO DUAL LUMEN UMBILICATH II-DL
K896041 · FOS
Gesco Intl., Inc.
General Hospital · 182d
Cleared Apr 17, 1990
BARD CONFORMACATH FOLEY CATHETER
K900229 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 17, 1990
BULB IRRIGATION TRAY
K900736 · EYN
Orion Life Systems, Inc.
General & Plastic Surgery · 60d
Cleared Apr 16, 1990
SIEMENS STEREODYNATOR 828
K881431 · IPF
Elmed, Inc.
Physical Medicine · 741d
Cleared Apr 16, 1990
PATIENT EXAMIN GLOVES(MFG: SHANGHAI FACTORY)
K894090 · LYY
Everbest Machinery (U.S.A.) Co. , Ltd.
General Hospital · 311d
Cleared Apr 16, 1990
EVOLUTION ULTRASONIC
K894215 · CCQ
Medical Industries America, Inc.
Anesthesiology · 301d
Cleared Apr 16, 1990
GLASION
K895386 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 229d
Cleared Apr 16, 1990
AHAC ITE MODEL ENTENDRE
K895843 · ESD
Aroostook Hearing Aid
Ear, Nose, Throat · 195d
Cleared Apr 16, 1990
URINARY LEG BAG
K896129 · FAQ
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 175d
Cleared Apr 16, 1990
SR-IVOCAP
K896130 · EBI
Ivoclar North America, Inc.
Dental · 175d
Cleared Apr 16, 1990
SR-IVOSEAL
K896139 · EBI
Ivoclar North America, Inc.
Dental · 175d
Cleared Apr 16, 1990
BIOPSY FORCEP (NON-ELECTRIC)
K896147 · FCL
Portlyn Corp.
Gastroenterology & Urology · 175d
Cleared Apr 16, 1990
RHINOMANOMETER
K896263 · BXQ
Jedmed Instrument Co.
Anesthesiology · 167d
Cleared Apr 16, 1990
TITAMED ANTWERP SYSTEM
K896404 · JEY
Optik
Dental · 160d
Cleared Apr 16, 1990
PPG BIOMEDICAL VENTILATOR MODEL IRISA
K896442 · CBK
Ppg Industries, Inc.
Anesthesiology · 158d
Cleared Apr 16, 1990
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST
K896492 · LQF
Gen-Probe, Inc.
Microbiology · 154d