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
36721–36744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2014
X-PORTE ULTRASOUND SYSTEM
K142017 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared Aug 21, 2014
IONSIL GEL
K132326 · FRO
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery · 391d
Cleared Aug 21, 2014
ALARIS SYSTEM WITH GUARDRAILS SUITE MX
K133532 · FRN
Carefusion 303, Inc.
General Hospital · 276d
Cleared Aug 21, 2014
GEKO
K133638 · IPF
Firstkind Limited
Physical Medicine · 267d
Cleared Aug 21, 2014
ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM
K133706 · DZE
Zl Microdent-Attachment GmbH & Co. KG
Dental · 261d
Cleared Aug 21, 2014
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
K140028 · DYB
Galt Medical Corp.
Cardiovascular · 227d
Cleared Aug 21, 2014
SB ANCHOR
K140600 · NHA
Osstem Implant Co., Ltd.
Dental · 164d
Cleared Aug 21, 2014
BELTER INFRA-RED EAR THERMOMETER
K140681 · FLL
Shenzhen Belter Health Measurement...
General Hospital · 156d
Cleared Aug 21, 2014
INTRAOSSEOUS FIXATION SYSTEM
K141004 · HTY
Orthohelix Surgical Designs, Inc.
Orthopedic · 125d
Cleared Aug 21, 2014
MEDLINE ANTI-EMBOLISM STOCKING
K141127 · DWL
Medline Industries, Inc.
General Hospital · 112d
Cleared Aug 21, 2014
SURGISEAL TWIST TOPICAL SKIN ADHESIVE
K141215 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 101d
Cleared Aug 21, 2014
TENSYN BAND, TENSYN FRACTURE PLATES
K141264 · HTN
Dallen Medical, Inc.
Orthopedic · 98d
Cleared Aug 21, 2014
BARRX FLEX RFA ENERGY GENERATOR
K141357 · GEI
Covidien Iic
General & Plastic Surgery · 90d
Cleared Aug 21, 2014
ROMEO 2 PAD POSTERIOR AXIAL DEVICE
K141508 · PEK
Spineart
Orthopedic · 76d
Cleared Aug 21, 2014
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
K141521 · LIT
Boston Scientific Corporation
Cardiovascular · 73d
Cleared Aug 21, 2014
IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM
K141567 · OAP
Apira Science, Inc.
General & Plastic Surgery · 70d
Cleared Aug 21, 2014
SMITH & NEPHEW DISPOSABLE FIN PUNCH
K141585 · JWH
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Aug 21, 2014
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
K141930 · NDN
Osseon, LLC
Orthopedic · 36d
Cleared Aug 21, 2014
SYMBIA 6.0
K142006 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 21, 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 17d
Cleared Aug 21, 2014
ORTHOHELIX STAPLE SYSTEM
K142148 · JDR
Orthohelix Surgical Designs, Inc.
Orthopedic · 16d
Cleared Aug 20, 2014
NEXUS MIDLINE CT CATHETER
K140270 · FOZ
Health Line International Corporation
General Hospital · 198d
Cleared Aug 20, 2014
ANKYLOS C/X IMPLANT SYSTEM
K140347 · DZE
Dentsply Intl., Inc.
Dental · 190d
Cleared Aug 20, 2014
HIOSSEN PROSTHETIC SYSTEM
K140507 · NHA
Osstem Implant Co., Ltd.
Dental · 174d