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
37681–37704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · HRS
Smith & Nephew, Inc.
Orthopedic · 36d
Cleared May 07, 2014
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
K140941 · FTL
Sofradim Production
General & Plastic Surgery · 23d
Cleared May 06, 2014
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K122656 · LYZ
Shandong Yifan Plastic Products Co.,...
General Hospital · 613d
Cleared May 06, 2014
DENRACLE DENTAL ABUTMENT
K131468 · NHA
Green Dentech Co, Ltd.
Dental · 350d
Cleared May 06, 2014
BD MAX(TM) ENTERIC BACTERIAL PANEL
K140111 · PCI
Becton, Dickinson and Company
Microbiology · 111d
Cleared May 06, 2014
RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
K140904 · PHX
Encore Medical, L.P.
Orthopedic · 27d
Cleared May 06, 2014
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
K140916 · JJY
Bio-Rad Laboratories
Chemistry · 26d
Cleared May 05, 2014
AIRVIEW MINI OWIE DICK TEST PACK
K133204 · JOJ
Crosstex International
General Hospital · 200d
Cleared May 05, 2014
INFILL CERVICAL
K140066 · ODP
Pinnacle Spine Group, LLC
Orthopedic · 115d
Cleared May 05, 2014
COBAS CT/NG V2.0 TEST
K140887 · LSL
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared May 05, 2014
HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM
K140899 · IYO
Halo Medical Technologies, LLC
Radiology · 27d
Cleared May 02, 2014
NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE
K132004 · OMP
Creo Quality, LLC
General & Plastic Surgery · 305d
Cleared May 02, 2014
ACCUTORR 7 VITAL SIGNS MONITOR
K132038 · MWI
Mindray North America
Cardiovascular · 305d
Cleared May 02, 2014
I-CHROMA IFOB WITH I-CHROMA READER
K132167 · OOX
Boditech Med, Inc.
Hematology · 294d
Cleared May 02, 2014
SHARPS CONTAINER
K132476 · MMK
Grp & Associates
General Hospital · 267d
Cleared May 02, 2014
PULMONE MINIBOX PFT TM
K133051 · BZC
Pulmone Advanced Medical Devices, Ltd.
Anesthesiology · 217d
Cleared May 02, 2014
MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE...
K133064 · DQA
Envitec-Wismar GmbH
Anesthesiology · 217d
Cleared May 02, 2014
NUVASIVE EMG ENDOTRACHEAL TUBE
K133530 · PDQ
Nu Vasive, Incorporated
Neurology · 168d
Cleared May 02, 2014
MATRIXRIB FIXATION SYSTEM
K133616 · HRS
Synthes USA Products, LLC
Orthopedic · 158d
Cleared May 02, 2014
MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC...
K133934 · FRO
Links Medical Products, Inc.
General & Plastic Surgery · 130d
Cleared May 02, 2014
GIGALASER
K134017 · ILY
Powermedic Aps
Physical Medicine · 123d
Cleared May 02, 2014
SWIFT-LOCK ANCHOR
K140272 · GZB
St Jude Medical
Neurology · 88d
Cleared May 02, 2014
FILMARRAY GASTROINTESTINAL (GI) PANEL
K140407 · PCH
Biofire Diagnostics
Microbiology · 73d
Cleared May 02, 2014
PROPELLER SYSTEM - MODEL 2
K140638 · CAF
Reciprocal Labs Corporation
Anesthesiology · 51d