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

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175,820 results
50089–50112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2010
ZEN CORDLESS PROPHY SYSTEM
K101612 · EKX
Discus Dental, LLC
Dental · 21d
Cleared Jun 29, 2010
WAVESTATE NEUROMONITOR
K092625 · ORT
Wavestate, Inc.
Neurology · 306d
Cleared Jun 29, 2010
WRIST ARTHRODESIS NAIL SYSTEM
K092720 · HSB
Skeletal Dynamics, LLC
Orthopedic · 298d
Cleared Jun 29, 2010
A4-XLR8 FOAM DRESSING
K092992 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 274d
Cleared Jun 29, 2010
NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION...
K093516 · LZA
Summit Glove, Inc.
General Hospital · 228d
Cleared Jun 29, 2010
NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT...
K093517 · LZA
Summit Glove, Inc.
General Hospital · 228d
Cleared Jun 29, 2010
LITETOUCH MASK
K100285 · CAF
Respironics New Jersey, Inc.
Anesthesiology · 148d
Cleared Jun 29, 2010
LATITUDE ELBOW PROSTHESIS
K100562 · JDB
Tornier, Inc.
Orthopedic · 120d
Cleared Jun 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965
K100940 · DXN
Andon Health Co, Ltd.
Cardiovascular · 85d
Cleared Jun 29, 2010
MODIFICATION TO INTEL HEALTH GUIDE PHS6000
K101178 · DRG
Intel Corp.
Cardiovascular · 63d
Cleared Jun 29, 2010
RII INFRARED EAR THERMOMETER, MODEL: TH60N
K101253 · FLL
Radiant Innovation, Inc.
General Hospital · 56d
Cleared Jun 29, 2010
FRANKENMAN SURGICAL STAPLERS
K101378 · GDW
Suzhou Frankenman Medical Equipment...
General & Plastic Surgery · 43d
Cleared Jun 29, 2010
BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
K101502 · JKA
Becton, Dickinson & CO
Chemistry · 28d
Cleared Jun 29, 2010
LIPCOLLECTOR II
K101713 · MUU
Human Med AG
General & Plastic Surgery · 11d
Cleared Jun 28, 2010
MEDPOR FIXATION SYSTEM
K091807 · JEY
Porex Surgical, Inc.
Dental · 375d
Cleared Jun 28, 2010
BELLECUP
K092985 · HHE
Librette, Inc.
Obstetrics & Gynecology · 273d
Cleared Jun 28, 2010
TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
K100322 · NBW
Taidoc Technology Corporation
Chemistry · 144d
Cleared Jun 28, 2010
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
K100947 · OPP
Calibra Medical, Inc.
General Hospital · 83d
Cleared Jun 28, 2010
G+ SYSTEM
K101344 · NDC
Glytec, LLC (Formally Known AS...
General Hospital · 46d
Cleared Jun 25, 2010
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
K083878 · GIR
R2 Diagnostics, Inc.
Hematology · 543d
Cleared Jun 25, 2010
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP...
K091327 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 416d
Cleared Jun 25, 2010
IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET
K091849 · MRG
Immunodiagnostic Systems, Inc.
Chemistry · 368d
Cleared Jun 25, 2010
SURGIMESH XD
K092233 · FTL
Aspide Medical
General & Plastic Surgery · 337d
Cleared Jun 25, 2010
SYNTEC OSTEO-PLATE AND SCREW FIXATION
K092889 · HRS
Syntec Scientific Corp.
Orthopedic · 277d