Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
38257–38280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2014
16 CH MULTIPURPOSE COIL VARIETY
K140252 · MOS
Noras Rontgen-Und Medizintechnik GmbH
Radiology · 97d
Cleared May 08, 2014
HERMES MEDICAL IMAGING SUITE V5.4
K140269 · KPS
Hermes Medical Solutions AB
Radiology · 94d
Cleared May 08, 2014
ELECSYS CK-MB STAT IMMUNOASSAY
K140404 · JHY
Roche Diagnostics
Chemistry · 79d
Cleared May 08, 2014
AAP LOQTEC(R) OLECRANON PLATE
K140607 · HRS
Aap Implantate AG
Orthopedic · 59d
Cleared May 08, 2014
ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS
K140755 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 43d
Cleared May 08, 2014
FILTEK BULK FILL POSTERIOR RESTROATIVE
K141081 · EBF
3M Espe Dental Products
Dental · 13d
Cleared May 07, 2014
GORE BIO-A WOUND MATRIX
K132397 · QSZ
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 279d
Cleared May 07, 2014
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
K132475 · OWN
Fluoptics
General & Plastic Surgery · 273d
Cleared May 07, 2014
Origio Gas Line Filter
K132870 · MQG
Origio, Inc.
Obstetrics & Gynecology · 236d
Cleared May 07, 2014
TRUE SPINAL FUSSION SYSTEM
K133690 · MNH
Innovative Surgical Designs
Orthopedic · 156d
Cleared May 07, 2014
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
K133801 · FRN
Baxter Healthcare Corporation
General Hospital · 145d
Cleared May 07, 2014
LUXER SHADED ZIRCONIA
K140070 · EIH
Continental Dental Ceramics, Inc.
Dental · 114d
Cleared May 07, 2014
EXCELLA III-D SPINAL DEFORMITY SYSTEM
K140238 · NKB
Innovasis, Inc.
Orthopedic · 97d
Cleared May 07, 2014
CARESITE LUER ACCESS DEVICE
K140311 · FPA
B.Braun Medical, Inc.
General Hospital · 89d
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