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

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176,076 results
77377–77400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2002
MEDIPORT 2000 MOBILE
K013585 · BTA
Servox Medizintechnik GmbH
General & Plastic Surgery · 90d
Cleared Jan 28, 2002
BCC GAMMA CAMERA
K013667 · KPS
Is2 Research, Inc.
Radiology · 83d
Cleared Jan 28, 2002
HI-ART SYSTEM
K013673 · MUJ
Tomo Therapy, Inc.
Radiology · 83d
Cleared Jan 28, 2002
JOBST READY-TO-WEAR GAUNTLET
K013852 · DWL
Bsn-Jobst, Inc.
General Hospital · 69d
Cleared Jan 28, 2002
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
K013922 · LLZ
Barco N.V.
Radiology · 62d
Cleared Jan 28, 2002
MINI SHOPPER
K013927 · INI
Shoprider Intl., Inc.
Physical Medicine · 61d
Cleared Jan 28, 2002
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
K013938 · KHP
Diametrics Medical, Inc.
Chemistry · 61d
Cleared Jan 28, 2002
WIENER LAB. ALP 405
K013983 · CJE
Wiener Laboratories Saic
Chemistry · 56d
Cleared Jan 28, 2002
DOC BAND
K014012 · OAN
Cranial Technologies, Inc.
Neurology · 54d
Cleared Jan 28, 2002
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED
K014021 · GAM
Surgical Specialties Corp
General & Plastic Surgery · 53d
Cleared Jan 28, 2002
NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING
K014055 · LYY
Seal Polymer Industries Bhd.
General Hospital · 49d
Cleared Jan 28, 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
K014103 · MRR
Beckman Coulter, Inc.
Chemistry · 46d
Cleared Jan 28, 2002
VOXAR'S CALCIUM SCORING PRODUCT
K020140 · LLZ
Voxar Limited
Radiology · 12d
Cleared Jan 25, 2002
CRYOCARE SURGICAL SYSTEM
K011074 · GEH
Endocare, Inc.
General & Plastic Surgery · 291d
Cleared Jan 25, 2002
KNEE MODULE FOR THE STEALTHSTATION SYSTEM
K012937 · HAW
Medtronic Surgical Navigation...
Neurology · 147d
Cleared Jan 25, 2002
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
K013091 · HBB
Von Zeppelin GmbH
Neurology · 130d
Cleared Jan 25, 2002
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
K013392 · OCL
Medtronic Vascular
Cardiovascular · 102d
Cleared Jan 25, 2002
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
K013507 · GZJ
Cosmo Health, Inc.
Neurology · 95d
Cleared Jan 25, 2002
KPS-I, THE KIDNEY PERFUSION SOLUTION
K013575 · KDN
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 25, 2002
PERICSCOPE, MODEL # PERISC1
K013576 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 88d
Cleared Jan 25, 2002
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
K013577 · DSY
Atrium Medical Corp.
Cardiovascular · 88d
Cleared Jan 25, 2002
PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · BSP
B.Braun Medical, Inc.
Anesthesiology · 81d
Cleared Jan 25, 2002
FINGER JOINT PROSTHESIS
K013629 · KYJ
Avanta Orthopaedics, Inc.
Orthopedic · 81d
Cleared Jan 25, 2002
RIBBOND - TRIAXIAL
K013881 · EBI
Ribbond, Inc.
Dental · 63d