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
106825–106848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1994
SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEM
K942740 · GCJ
Sharplan Lasers, Inc.
General & Plastic Surgery · 74d
Cleared Aug 23, 1994
TROCAR WITH SHIELD
K942819 · GCJ
Mahe-Medizintechnik
General & Plastic Surgery · 70d
Cleared Aug 23, 1994
LASER GAS MIXTURE
K942865 · GEX
Nordan Smith Welding Supplies
General & Plastic Surgery · 67d
Cleared Aug 23, 1994
SPIRIT MB
K943245 · DYW
Sybron Dental Specialties, Inc.
Dental · 48d
Cleared Aug 23, 1994
GAUZE SPONGE (E.W.A. LTD./VARIOUS)
K943339 · EFQ
E.W.A., Ltd.
General & Plastic Surgery · 42d
Cleared Aug 23, 1994
PERMAGEN F/DC
K943373 · KLE
Ultradent Products, Inc.
Dental · 41d
Cleared Aug 23, 1994
SIDE-FIRING UROLOGIC REFRACTIVE FIBER
K943409 · GEX
Energy Life Systems Corp.
General & Plastic Surgery · 40d
Cleared Aug 23, 1994
CAPTURE IMPRESSION MATERIAL
K943574 · ELW
Dentsply Intl.
Dental · 32d
Cleared Aug 23, 1994
MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER
K943578 · FMI
Sherwood Medical Co.
General Hospital · 32d
Cleared Aug 23, 1994
KARL STORZ BRONCHOSCOPE ACCESSORIES
K943700 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 22, 1994
DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL
K934318 · LNH
Diagnostic Instrument Corp.
Radiology · 355d
Cleared Aug 22, 1994
STONE EXTRACTOR
K935721 · FFL
Boston Scientific Corp
Gastroenterology & Urology · 265d
Cleared Aug 22, 1994
UROVIEW MODEL 2600
K940295 · JAA
Ge Dec Medical Systems
Radiology · 213d
Cleared Aug 22, 1994
MS AMPLATZ EXTRA STIFF GUIDE WIRE
K942382 · DQX
Meadox Surgimed, Inc.
Cardiovascular · 95d
Cleared Aug 22, 1994
DERMIVIEW CLEAR TAPE
K942383 · KGX
Johnson & Johnson International
General & Plastic Surgery · 95d
Cleared Aug 22, 1994
AIRWAY CONNECTOR WITH FLEX TUBE
K942392 · BZA
Mallinckrodt Medical
Anesthesiology · 95d
Cleared Aug 22, 1994
HYGROLIFE
K942794 · BYD
Mallinckrodt Medical
Anesthesiology · 69d
Cleared Aug 22, 1994
SIEMENS BTE HEARING AIDS
K942857 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 67d
Cleared Aug 22, 1994
AUTO SUTURE MODIFIED GRIP
K942885 · FBQ
United States Surgical, A Division of...
General & Plastic Surgery · 66d
Cleared Aug 22, 1994
SUTURE REMOVAL TRAYS
K943090 · FRG
Sterile Concepts, Inc.
General Hospital · 55d
Cleared Aug 22, 1994
VASCULAR MP X-RAY GENERATOR
K943652 · IZO
GE Medical Systems
Radiology · 25d
Cleared Aug 22, 1994
PULSEMASTER S SERIES
K943693 · GEX
Incisive Technologies, Inc.
General & Plastic Surgery · 24d
Cleared Aug 22, 1994
AUDILENS LLK
K943706 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 21d
Cleared Aug 22, 1994
SURGICAL BUR
K943758 · GFF
Komet Medical
General & Plastic Surgery · 20d