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
74377–74400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2002
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K022687 · LYL
Ciba Vision Corporation
Ophthalmic · 98d
Cleared Nov 19, 2002
MANUAL TOUCHE SYSTEM
K022777 · GAQ
Onux Medical, Inc.
General & Plastic Surgery · 90d
Cleared Nov 19, 2002
TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM
K022783 · DXN
Tensys Medical, Inc.
Cardiovascular · 89d
Cleared Nov 19, 2002
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES...
K022798 · KWQ
Corin USA
Orthopedic · 88d
Cleared Nov 19, 2002
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
K022841 · GZJ
Biomedical Life Systems, Inc.
Neurology · 84d
Cleared Nov 19, 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
K022925 · GZJ
Biomedical Life Systems, Inc.
Neurology · 76d
Cleared Nov 19, 2002
THE BIOPLATE BATTERY POWERED DRILL
K022986 · HBC
Bioplate, Inc.
Neurology · 71d
Cleared Nov 19, 2002
MONARC SLING SYSTEM
K023516 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 19, 2002
EASY LIFE
K023521 · INO
Berkline Corp.
Physical Medicine · 29d
Cleared Nov 19, 2002
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K023570 · MQP
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Nov 19, 2002
STORM TDX POWER WHEELCHAIR
K023589 · ITI
Invacare Corp.
Physical Medicine · 25d
Cleared Nov 19, 2002
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
K023601 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 22d
Cleared Nov 19, 2002
TILITE YG AND TILITE YGS
K023606 · IOR
Tisport
Physical Medicine · 22d
Cleared Nov 19, 2002
BIOBUCK CEMENT RESTRICTOR
K023680 · LZN
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Nov 19, 2002
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
K023698 · MHX
Philips Medical Systems
Cardiovascular · 15d
Cleared Nov 19, 2002
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
K023749 · DRG
Philips Medical Systems
Cardiovascular · 11d
Cleared Nov 18, 2002
RENAX HEMODIALYSIS BLOOD TUBING SET
K014140 · FJK
Sunder Biomedical Tech. Co., Ltd.
Gastroenterology & Urology · 336d
Cleared Nov 18, 2002
BAXTER ACCURA SYSTEM, MODEL 5M5660
K021615 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 186d
Cleared Nov 18, 2002
IDI-STREP B ASSAY
K022504 · NJR
Infectio Diagnostic, Inc.
Microbiology · 112d
Cleared Nov 18, 2002
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES
K022671 · LZA
Hartalega Sdn Bhd
General Hospital · 98d
Cleared Nov 18, 2002
MILLENNIUM MICROSURGICAL SYSTEM
K022760 · GEX
Bausch & Lomb, Inc.
General & Plastic Surgery · 90d
Cleared Nov 18, 2002
AMEDITECH IMMUTEST HCG PREGANCY TEST
K023126 · LCX
Ameditech, Inc.
Chemistry · 60d
Cleared Nov 18, 2002
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K023184 · DIC
Bayer Diagnostics Corp.
Chemistry · 55d
Cleared Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310,...
K023337 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 42d