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
120985–121008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1991
ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE
K903176 · GAW
Advance Suture, Inc.
General & Plastic Surgery · 345d
Cleared Jun 28, 1991
ADVANCE SUTURE NONABSORBABLE NYLON SUTURE
K903177 · GAR
Advance Suture, Inc.
General & Plastic Surgery · 345d
Cleared Jun 28, 1991
EYEOPENER
K904469 · JYJ
Kc Medical Industries
Ear, Nose, Throat · 270d
Cleared Jun 28, 1991
UNIVERSAL COMPRESSION SCREW
K904809 · HWC
Howmedica Corp.
Orthopedic · 247d
Cleared Jun 28, 1991
EXTEND TRACK UNIT
K904963 · BXB
Anthony Chiropractic Clinic, Inc.
Physical Medicine · 235d
Cleared Jun 28, 1991
ADVANCE SUTURE NONABSORBABLE SILK SUTURE
K905454 · GAP
Advance Suture, Inc.
General & Plastic Surgery · 205d
Cleared Jun 28, 1991
STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
K905504 · LYF
Dako Corp.
Microbiology · 203d
Cleared Jun 28, 1991
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
K905594 · GWK
Nihon Kohden America, Inc.
Neurology · 197d
Cleared Jun 28, 1991
SUH VENT TUBE
K910618 · ETD
Boston Medical Products, Inc.
Ear, Nose, Throat · 136d
Cleared Jun 28, 1991
COOK TISSUE MORCELLATOR
K910939 · GEI
Cook Urological, Inc.
General & Plastic Surgery · 114d
Cleared Jun 28, 1991
SOREX SAFE-AIR
K911150 · GEX
Sorex Medical
General & Plastic Surgery · 105d
Cleared Jun 28, 1991
VLC GLASS IONOMER LINER
K911244 · EJK
Dentsply Intl.
Dental · 99d
Cleared Jun 28, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY
K911276 · LNH
Toshiba America Mri, Inc.
Radiology · 95d
Cleared Jun 28, 1991
LIMA CEMENT RESTRICTOR
K911338 · JDK
Turnkey Intergration USA, Inc.
Orthopedic · 94d
Cleared Jun 28, 1991
PS MEDICAL BUTTON VALVE
K911410 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 88d
Cleared Jun 28, 1991
OLYMPUS DISPOSABLE BIOPSY VALVE
K911412 · EOQ
Olympus Corp.
Ear, Nose, Throat · 88d
Cleared Jun 28, 1991
HISTOFREEZER
K911420 · GEH
Solarcare Technologies Corp,Inc.
General & Plastic Surgery · 88d
Cleared Jun 28, 1991
FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM
K911445 · JDR
Neoligaments, Ltd.
Orthopedic · 86d
Cleared Jun 28, 1991
ISOLA(TM) SPINE SYSTEM - ILIAC SCREW
K911528 · KWP
Acromed Corp.
Orthopedic · 85d
Cleared Jun 28, 1991
ACRYL-X SYSTEM TM
K911548 · JDX
Sonokinetics, Inc.
Orthopedic · 81d
Cleared Jun 28, 1991
ANATOMIC TOE SYSTEM
K911552 · LZJ
Orthopaedic Biosystems
Orthopedic · 81d
Cleared Jun 28, 1991
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
K911613 · LCR
Exmoor Plastics , Ltd.
Toxicology · 86d
Cleared Jun 28, 1991
CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
K911703 · DQO
Cordis Corp.
Cardiovascular · 73d
Cleared Jun 28, 1991
PHILIPS TELESCAN
K911773 · LMD
Philips Medical Systems, Inc.
Radiology · 70d