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
43585–43608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2012
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER,...
K120759 · CGA
I-Sens, Inc.
Chemistry · 84d
Cleared Jun 05, 2012
CENTRICITY PACS-IW
K121387 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 28d
Cleared Jun 05, 2012
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
K121515 · ONF
Solta Medical, Inc.
General & Plastic Surgery · 14d
Cleared Jun 04, 2012
SNORKEL
K112766 · LQZ
Fellmar Company
Dental · 256d
Cleared Jun 04, 2012
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
K120370 · OQG
Zimmer, Inc.
Orthopedic · 119d
Cleared Jun 04, 2012
BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR
K120435 · JOJ
STERIS Corporation
General Hospital · 112d
Cleared Jun 04, 2012
MACH BRACKETS BRIGHT BRACKETS
K120471 · NJM
World Bio Tech Co., Ltd.
Dental · 109d
Cleared Jun 04, 2012
S-250 PROTON BEAM RADIATION THERAPY SYSTEM
K120676 · LHN
Mevion Medical Systems
Radiology · 91d
Cleared Jun 04, 2012
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
K120689 · HRS
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Jun 04, 2012
LIGHT FOR WRINKLES
K120775 · OHS
Led Intellectual Properties, LLC
General & Plastic Surgery · 82d
Cleared Jun 04, 2012
TRILLIANT SURGICAL K-WIRES
K121008 · HTY
Trilliant Surgical, Ltd.
Orthopedic · 62d
Cleared Jun 04, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
K121035 · EOQ
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Jun 04, 2012
CROSSFIX II MEMISCAL REPAIR DEVICE
K121413 · GAT
Cayenne Medical, Inc.
General & Plastic Surgery · 24d
Cleared Jun 03, 2012
MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES
K113597 · GEI
Minilap Technologies
General & Plastic Surgery · 181d
Cleared Jun 03, 2012
THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
K120661 · FMI
Vidacare Corporation
General Hospital · 90d
Cleared Jun 01, 2012
STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN,...
K111798 · DZE
Sterngold Dental, LLC
Dental · 340d
Cleared Jun 01, 2012
COLLAGEN WOUND DRESSING
K112580 · KGN
Dalim Tissen Co., Ltd.
General & Plastic Surgery · 269d
Cleared Jun 01, 2012
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
K112900 · HSD
Lima Corporate S.P.A.
Orthopedic · 242d
Cleared Jun 01, 2012
MRSA/SA ELITE MGB
K112937 · NQX
Elitech
Microbiology · 242d
Cleared Jun 01, 2012
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT,...
K113438 · JMO
Alfa Wassermann Diagnostic...
Chemistry · 193d
Cleared Jun 01, 2012
BORRELIA BURGDORFERI IGM BLOT TEST
K113846 · LSR
Gold Standard Diagnostics
Microbiology · 155d
Cleared Jun 01, 2012
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K120346 · MCW
Rex Medical
Cardiovascular · 119d
Cleared Jun 01, 2012
CARDINAL HEALTH DURABLUE STERILIZATION WRAP
K120542 · FRG
Cardinal Health-Medical Products and...
General Hospital · 99d
Cleared Jun 01, 2012
VANTAGE TITAN
K120638 · LNH
Toshibamedical Systems Corporation
Radiology · 92d