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
52801–52824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2009
PASSPORT V MONITOR, MODEL 0998-00-6100
K091834 · MHX
Datascope Corp., Patient Monitoring...
Cardiovascular · 23d
Cleared Jul 14, 2009
NUTRAC PELVATOR, MODEL PEL 200
K083704 · KPI
Verity Scientific , Ltd.
Gastroenterology & Urology · 211d
Cleared Jul 14, 2009
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
K090389 · NBW
Bestgen Biotech Corp.
Chemistry · 147d
Cleared Jul 14, 2009
SINUS QUICK IT SYSTEM
K090527 · DZE
Neobiotech Co., Ltd.
Dental · 138d
Cleared Jul 14, 2009
PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260
K090655 · IZL
Source-Ray, Inc.
Radiology · 125d
Cleared Jul 14, 2009
VALOR ANKLE FUSION NAIL SYSTEM
K090857 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 106d
Cleared Jul 14, 2009
ZYFUSE FACET FIXATION SYSTEM
K090952 · MRW
Globus Medical, Inc.
Orthopedic · 102d
Cleared Jul 14, 2009
5.5 POLARIS SPINAL SYSTEM
K091067 · NKB
Biomet Spine
Orthopedic · 91d
Cleared Jul 14, 2009
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
K091088 · ODP
Ldr Spine USA
Orthopedic · 90d
Cleared Jul 14, 2009
MINITAPE URETHRAL SLING
K091180 · PAH
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 82d
Cleared Jul 14, 2009
CORONIS 5MP HD, MODEL MDMG 5121
K091274 · LLZ
Barco N.V.
Radiology · 75d
Cleared Jul 14, 2009
RALCO, MODEL R225 ACS
K091517 · IZW
Ralco S.R.L.
Radiology · 53d
Cleared Jul 14, 2009
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
K091751 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Jul 14, 2009
WATERLASE C100, MODEL 7100104
K091922 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 14d
Cleared Jul 13, 2009
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
K090188 · NBW
Taidoc Technology Corporation
Chemistry · 168d
Cleared Jul 13, 2009
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153 · KHS
Beckman Coulter, Inc.
Chemistry · 83d
Cleared Jul 13, 2009
APTUS FOOT SYSTEM
K091479 · HRS
Medartis AG
Orthopedic · 55d
Cleared Jul 10, 2009
NEWDEAL HALLU LOCK PLATE SYSTEM
K083154 · HRS
Newdeal Sas
Orthopedic · 259d
Cleared Jul 10, 2009
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K083712 · FIP
Dipure, LLC
Gastroenterology & Urology · 207d
Cleared Jul 10, 2009
COOK UROLOGICAL GRAFT
K090688 · PAG
Cook Biotech, Inc.
Gastroenterology & Urology · 116d
Cleared Jul 10, 2009
GMK TOTAL KNEE SYSTEM
K090988 · JWH
Medacta International S.A.
Orthopedic · 94d
Cleared Jul 10, 2009
SYNTHES ORACLE PLATE
K091159 · KWQ
Synthes Spine
Orthopedic · 80d
Cleared Jul 10, 2009
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
K091689 · KWP
Synthes (Usa)
Orthopedic · 30d
Cleared Jul 10, 2009
M3 MONITOR
K091908 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 15d