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
67969–67992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2004
ENDOTINE MIDFACE B 4.5 DEVICE
K041835 · HWC
Coapt Systems, Inc.
General & Plastic Surgery · 83d
Cleared Sep 28, 2004
VALUPEN,PROFILE
K041868 · GEI
Conmed Corporation
General & Plastic Surgery · 81d
Cleared Sep 28, 2004
HEMOSIL CALIBRATION PLASMA
K041905 · JIX
Instrumentation Laboratory CO
Hematology · 75d
Cleared Sep 28, 2004
POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
K042141 · GAM
Teleflex Medical
General & Plastic Surgery · 50d
Cleared Sep 28, 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K042233 · GAM
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 41d
Cleared Sep 27, 2004
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER
K041914 · MSD
Kendall
Gastroenterology & Urology · 73d
Cleared Sep 27, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K042303 · JJX
Ortho-Clinical Diagnostics
Microbiology · 33d
Cleared Sep 27, 2004
ALLURA 3D-CA, RELEASE 1
K042334 · LLZ
Philips Medical Systems North America...
Radiology · 28d
Cleared Sep 27, 2004
UBIPACS
K042507 · LLZ
Icm Co., Ltd.
Radiology · 12d
Cleared Sep 24, 2004
FIDIS CELIAC
K041002 · MST
Biomedical Diagnostics S.A.
Immunology · 158d
Cleared Sep 24, 2004
PERSONAL LUBRICATING GEL
K041129 · NUC
Qualis, Inc.
Obstetrics & Gynecology · 147d
Cleared Sep 24, 2004
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
K041349 · CHP
Ibl GmbH
Chemistry · 127d
Cleared Sep 24, 2004
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
K041792 · KDJ
Fresenius Medical Care North America
Gastroenterology & Urology · 84d
Cleared Sep 24, 2004
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
K041837 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 79d
Cleared Sep 24, 2004
ST360 SPINAL FIXATION SYSTEM
K041925 · KWP
Zimmer Spine, Inc.
Orthopedic · 67d
Cleared Sep 24, 2004
POWER SCOOTER, MODEL TL0821
K042011 · INI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 60d
Cleared Sep 24, 2004
TEH LIN POWER SCOOTER, MODEL TL-822
K042012 · INI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 60d
Cleared Sep 24, 2004
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K042019 · KTT
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 24, 2004
KODAK MEDICAL IMAGER 300
K042158 · LMC
Eastman Kodak Company
Radiology · 45d
Cleared Sep 24, 2004
KODAK COLOR MEDICAL IMAGER 1000
K042159 · LMC
Eastman Kodak Company
Radiology · 45d
Cleared Sep 24, 2004
PS MEDICAL NEUROSURGICAL IMPLANTS
K042198 · JXG
Medtronic Neurosurgery
Neurology · 42d
Cleared Sep 24, 2004
LEONARDO SYNGO CARDIOLOGY WORKSTATION
K042203 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 39d
Cleared Sep 24, 2004
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
K042312 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 24, 2004
CERVICAL PLATE
K042317 · KWQ
Scient'X
Orthopedic · 29d