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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
74041–74064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2002
TILITE EVO
K024055 · IOR
Tisport, LLC
Physical Medicine · 11d
Cleared Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · HWC
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING,...
K024106 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 7d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING,...
K024121 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 4d
Cleared Dec 19, 2002
VIABIL BILIARY ENDOPROSTHESIS
K014215 · FGE
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 363d
Cleared Dec 19, 2002
ACELL UBM LYOPHILIZED WOUND DRESSING
K021637 · KGN
Acell, Inc.
General & Plastic Surgery · 216d
Cleared Dec 19, 2002
REFLECTION CONSTRAINED LINER
K021803 · KWZ
Smith & Nephew, Inc.
Orthopedic · 199d
Cleared Dec 19, 2002
TRANSITIONAL IMPLANTS
K021915 · DZE
Intra-Lock International
Dental · 191d
Cleared Dec 19, 2002
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
K022660 · DRR
Biocheck, Inc.
Chemistry · 132d
Cleared Dec 19, 2002
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
K022715 · GAM
Ethicon, Inc.
General & Plastic Surgery · 126d
Cleared Dec 19, 2002
PHILIPS EASYVISION WORKSTATION RELEASE 6
K023137 · LLZ
Philips Medical Systems North America...
Radiology · 90d
Cleared Dec 19, 2002
ECHO SOUNDER, ES-102EX
K023143 · KNG
Koven Technology, Inc.
Radiology · 90d
Cleared Dec 19, 2002
MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
K023264 · FRN
Alaris Medical Systems, Inc.
General Hospital · 80d
Cleared Dec 19, 2002
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
K023280 · GEI
Olympus Optical Co., Ltd.
General & Plastic Surgery · 79d
Cleared Dec 19, 2002
STEELEX STERNUM SET
K023411 · GAQ
Aesculap, Inc.
General & Plastic Surgery · 69d
Cleared Dec 19, 2002
BIOPSY SITE TISSUE MARKER DEVICE
K023450 · NEU
Promex, Inc.
General & Plastic Surgery · 65d
Cleared Dec 19, 2002
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE...
K023669 · JJY
Medical Analysis Systems, Inc.
Chemistry · 49d
Cleared Dec 19, 2002
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · MQV
Synthes (Usa)
Orthopedic · 29d
Cleared Dec 19, 2002
SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND...
K024011 · NLU
Surgical Instruments Service and...
Gastroenterology & Urology · 15d
Cleared Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · JFY
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Dec 18, 2002
ANTI-SNORING DEVICE OR ASD
K011723 · LRK
Pi Medical
Dental · 562d
Cleared Dec 18, 2002
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 126d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944 · MSV
Hycor Biomedical, Inc.
Immunology · 104d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
K022945 · MSV
Hycor Biomedical, Inc.
Immunology · 104d