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
104017–104040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1995
LAPAROSCOPE, HAND INSTRUMENTS
K950103 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 54d
Cleared Mar 06, 1995
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
K950507 · GEI
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 28d
Cleared Mar 06, 1995
CANDELA URETHRAL/BLADDER SOUND
K950633 · FBX
Candela Laser Corp.
Gastroenterology & Urology · 21d
Cleared Mar 06, 1995
UCB
K950689 · MNL
Cox Medical Ent., Inc.
Gastroenterology & Urology · 20d
Cleared Mar 06, 1995
CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE)
K950744 · GCJ
Stephen Chakoff, Inc.
General & Plastic Surgery · 17d
Cleared Mar 06, 1995
CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES)
K950745 · GCJ
Stephen Chakoff, Inc.
General & Plastic Surgery · 17d
Cleared Mar 06, 1995
CHAKOFF ENDOSCOPY (SET LAPAROSCOPY)
K950746 · GCJ
Stephen Chakoff, Inc.
General & Plastic Surgery · 17d
Cleared Mar 06, 1995
CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.)
K950747 · GCJ
Stephen Chakoff, Inc.
General & Plastic Surgery · 17d
Cleared Mar 06, 1995
CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE)
K950748 · GCJ
Stephen Chakoff, Inc.
General & Plastic Surgery · 17d
Cleared Mar 06, 1995
OLYMPUS BIOPSY FORCEPS MODEL FB-44
K950786 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 06, 1995
RUTNER BIOPSY DEVICE
K950810 · FCG
Cook Urological, Inc.
Gastroenterology & Urology · 12d
Cleared Mar 03, 1995
PRESPO 7, SELF-SUFFICIENT DRIP DEVICE
K933848 · FPA
Bonding Corp.
General Hospital · 574d
Cleared Mar 03, 1995
LUNG DIFFUSION
K942864 · BZC
Nordan Smith Welding Supplies
Anesthesiology · 259d
Cleared Mar 03, 1995
MEDX REUSABLE SHARPS CONTAINER
K943771 · FMI
Bfi- Medical Waste Systems
General Hospital · 213d
Cleared Mar 03, 1995
CONTROL
K944284 · DQO
Daig Corp.
Cardiovascular · 182d
Cleared Mar 03, 1995
SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS
K944668 · DQY
Medtronics Interventional Vascular
Cardiovascular · 171d
Cleared Mar 03, 1995
SCIMED CHIOCE PLUS PTCA GUIDE WIRE
K945129 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 135d
Cleared Mar 03, 1995
MICROPLATE PROCESSOR 3000
K945135 · JJE
Organon Teknika Corp.
Chemistry · 134d
Cleared Mar 03, 1995
WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS
K945494 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 115d
Cleared Mar 03, 1995
PREMIER(TM) H. PYLORY
K945558 · LYR
Meridian Diagnostics, Inc.
Microbiology · 109d
Cleared Mar 03, 1995
SILON(R) SILICONE THERMOPLASTIC SHEETING
K945892 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 91d
Cleared Mar 03, 1995
NON-PRESCRIPTION SUNGLASSES
K945922 · HQY
Csi Industries, Inc.
Ophthalmic · 88d
Cleared Mar 03, 1995
RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE
K945931 · DTL
Research Industries Corp.
Cardiovascular · 88d
Cleared Mar 03, 1995
GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE)
K945953 · GCJ
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 87d