FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76249–76272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2002
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
K020012 · DQO
Boston Scientific/Medi-Tech
Cardiovascular · 26d
Cleared Jan 29, 2002
COOLBLU2 DENTAL RESIN CURING DEVICE
K020171 · EBZ
Dental Systems.Com, Inc.
Dental · 12d
Cleared Jan 28, 2002
SALINE IV FLUSH SYRINGE
K002142 · FOZ
Emt-Rx
General Hospital · 560d
Cleared Jan 28, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K010378 · MQP
Implex Corp.
Orthopedic · 354d
Cleared Jan 28, 2002
DEPUY FEMORAL HEADS
K011533 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 255d
Cleared Jan 28, 2002
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM
K012089 · DQK
Catheffects, LLC
Cardiovascular · 207d
Cleared Jan 28, 2002
EXCITE SELF ETCH
K013584 · KLE
Ivoclar Vivadent, Inc.
Dental · 90d
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