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
108769–108792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1994
BARD APII PUMP
K926385 · FRN
C.R. Bard, Inc.
General Hospital · 482d
Cleared Apr 18, 1994
INSUFO-GARD #100-104
K930767 · HIF
Acorn Medical, Inc.
Obstetrics & Gynecology · 430d
Cleared Apr 18, 1994
INSUFFLATOR TUBING KIT W/FILTER
K933094 · HIF
Inman Medical Corp.
Obstetrics & Gynecology · 298d
Cleared Apr 18, 1994
VISION FX 40 & 80 SERIES GAMMA CAMERA
K935273 · IYX
Summit Nuclear
Radiology · 167d
Cleared Apr 18, 1994
PF404/409/410/411/416/418 W/PF319:0/319:1/319:2
K935495 · GEX
Perimed, Inc.
General & Plastic Surgery · 154d
Cleared Apr 18, 1994
UROGRAM CYSTOMETROGRAM
K936041 · FEN
Myo/Kinetic Systems, Inc.
Gastroenterology & Urology · 119d
Cleared Apr 18, 1994
INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
K940232 · GCJ
Innerdyne Medical, Inc.
General & Plastic Surgery · 94d
Cleared Apr 18, 1994
NAMIC ARIA(TM) INFLATION DEVICE
K940542 · EZN
American Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 18, 1994
ACUCISE GUIDEWIRE EXCHANGE SHEATH
K941010 · EYB
Applied Medical Resources
Gastroenterology & Urology · 46d
Cleared Apr 18, 1994
LOW PRESSURE TAMPONADE BALLOON CATHETER
K941012 · EYB
Applied Medical Resources
Gastroenterology & Urology · 46d
Cleared Apr 15, 1994
ARTHREX ARTHROSCOPE
K921119 · HRX
Arthrex, Inc.
Orthopedic · 767d
Cleared Apr 15, 1994
SES-2012 AUTOMATIC STEAM STERILIZER
K924596 · FLE
Porter Instrument Co., Inc.
General Hospital · 581d
Cleared Apr 15, 1994
POSICAST IMMOBILIZATION SYSTEM
K926187 · IYE
Huestis Machine Corp.
Radiology · 493d
Cleared Apr 15, 1994
SILICONE FOLEY CATHETER
K930344 · EZL
Cook Urological, Inc.
Gastroenterology & Urology · 445d
Cleared Apr 15, 1994
PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH
K931173 · FPA
Imed Corp.
General Hospital · 403d
Cleared Apr 15, 1994
RIWOLITH 2280 PROBES
K931755 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 372d
Cleared Apr 15, 1994
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
K932120 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 347d
Cleared Apr 15, 1994
FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR
K932137 · FXX
Tecnol Medical Products, Inc.
General Hospital · 353d
Cleared Apr 15, 1994
YOUNG D'GRANULATOR
K932255 · KMW
Young Dental Manufacturing Co. 1, LLC
Dental · 340d
Cleared Apr 15, 1994
MODEL ELI 300 ELECTROCARDIOGRAPH
K933143 · LOS
Mortara Instrument, Inc.
Cardiovascular · 291d
Cleared Apr 15, 1994
CEBOPLANE
K933933 · HTZ
Synvasive Technology, Inc.
General & Plastic Surgery · 247d
Cleared Apr 15, 1994
LINVATEC POWERLINK SURGICAL SHAVING SYSTEM
K934379 · HRX
Linvatec Corp.
Orthopedic · 219d
Cleared Apr 15, 1994
PDS ULTRACLEAN
K934666 · FLG
Medical Polymers, Inc.
General Hospital · 199d
Cleared Apr 15, 1994
SORIN BLOOD CARDIOPLEGIA SYSTEM
K934763 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 192d