FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
41977–42000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2012
ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K122213 · LPL
Soflex Limited
Ophthalmic · 140d
Cleared Dec 12, 2012
VASU-PICC
K122423 · LJS
Medical Components, Inc.
General Hospital · 125d
Cleared Dec 12, 2012
STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
K122555 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 112d
Cleared Dec 12, 2012
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
K122571 · NKB
Seaspine, Inc.
Orthopedic · 111d
Cleared Dec 12, 2012
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · FED
Boston Scientific Corp
Gastroenterology & Urology · 104d
Cleared Dec 12, 2012
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
K122855 · DZE
Straumann USA
Dental · 85d
Cleared Dec 12, 2012
LENSX LASER SYSTEM
K123120 · OOE
Alcon Lensx, Inc.
Ophthalmic · 70d
Cleared Dec 12, 2012
MOSAIQ ONCOLOGY INFORMATION SYSTEM
K123230 · IYE
Impac Medical Systems, Inc.
Radiology · 58d
Cleared Dec 12, 2012
S4 SPINAL SYSTEM
K123352 · NKB
Aesculap Implant Systems, Inc.
Orthopedic · 42d
Cleared Dec 11, 2012
MAVRIC SL
K113394 · LNH
Ge Medical Systems, LLC
Radiology · 391d
Cleared Dec 11, 2012
NIXALL TM WOUND AND SKIN CARE
K113693 · FRO
Seriously Clean, Ltd.
General & Plastic Surgery · 361d
Cleared Dec 11, 2012
QUARK SERIES
K120146 · CBK
Cosmed Srl
Anesthesiology · 328d
Cleared Dec 11, 2012
BPA-FREE MICROHYBID COMPOSITE
K120237 · EBF
Novocol, Inc.
Dental · 320d
Cleared Dec 11, 2012
NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
K120356 · MBI
Ncs Lab Srl
Orthopedic · 309d
Cleared Dec 11, 2012
AMBIENT TURBOFLASH 90 IFS
K120791 · GEI
Arthocare Corporation
General & Plastic Surgery · 271d
Cleared Dec 11, 2012
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K120866 · NBW
Delbio Incorporation
Chemistry · 264d
Cleared Dec 11, 2012
CARDIOSCOPE
K121266 · DXN
Pulsecor Limited
Cardiovascular · 229d
Cleared Dec 11, 2012
ULTRASONIC SURGERY
K121620 · DZI
Dmetec.Co., Ltd.
Dental · 193d
Cleared Dec 11, 2012
NP-CAST ABUTMENT SYSTEM
K121843 · NHA
Osstem Implant Co., Ltd.
Dental · 169d
Cleared Dec 11, 2012
PBP TOTAL HIP SYSTEM
K122158 · OQG
Pipeline Biomedical Products, LLC
Orthopedic · 144d
Cleared Dec 11, 2012
ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS
K122268 · NHA
Dentsply International
Dental · 134d
Cleared Dec 11, 2012
TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE...
K122421 · EJK
Kuraray Noritake Dental, Inc.
Dental · 124d
Cleared Dec 11, 2012
MTA2 ROOT AND PULP MATERIALS
K122892 · KIF
Avalon Biomed, Inc.
Dental · 82d
Cleared Dec 11, 2012
GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM*...
K122980 · DYB
Terumo Medical Corporation
Cardiovascular · 76d