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
90169–90192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1998
NEUROAMP EEG AMPLIFIER
K974495 · GWQ
Neurocorp, Ltd.
Neurology · 90d
Cleared Feb 26, 1998
STRATIS II
K974498 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 90d
Cleared Feb 26, 1998
INTROSYTE CATHETER
K974764 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 69d
Cleared Feb 26, 1998
PROMAX SURGICAL DRAPES AND COVERS
K980183 · KKX
Standard Textile Co., Inc.
General Hospital · 37d
Cleared Feb 26, 1998
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
K980509 · IMD
Deroyal Industries, Inc.
Physical Medicine · 16d
Cleared Feb 25, 1998
BPX80 BIO-PUMP (BPX80)
K973011 · KFM
Medtronic Bio-Medicus, Inc.
Cardiovascular · 196d
Cleared Feb 25, 1998
READYCATH CATHETER
K973120 · GBM
Medical Technologies of Georgia
Gastroenterology & Urology · 189d
Cleared Feb 25, 1998
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST
K973269 · JXM
Drial Consultants, Inc.
Toxicology · 180d
Cleared Feb 25, 1998
D/SENSE-T
K973285 · KLE
Centrix, Inc.
Dental · 176d
Cleared Feb 25, 1998
VOICE MASTER PROSTHESIS
K974132 · EWL
E. Benson Hood Lab, Inc.
Ear, Nose, Throat · 114d
Cleared Feb 25, 1998
ERECAID SYSTEM/STAY EREC SYSTEM
K974173 · LKY
Imagyn Medical Technologies, Inc.
Gastroenterology & Urology · 112d
Cleared Feb 25, 1998
CPD COMMANDER
K974253 · MRH
Scieran Technologies, Inc.
Ophthalmic · 104d
Cleared Feb 25, 1998
ECAT PET SCANNERS
K974256 · KPS
Cti Pet Systems, Inc.
Radiology · 104d
Cleared Feb 25, 1998
3D I-SCAN
K974522 · IYO
Ophthalmic Technologies, Inc.
Radiology · 85d
Cleared Feb 25, 1998
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K974619 · LMA
Afp Imaging Corp.
Radiology · 76d
Cleared Feb 25, 1998
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN...
K974658 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 72d
Cleared Feb 25, 1998
NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE
K974710 · LZA
Sinochem Ningbo Latex Gloves Factory
General Hospital · 70d
Cleared Feb 25, 1998
CREATINE KINASE REAGENT
K980012 · JHX
Ac Biochemicals, Inc.
Chemistry · 54d
Cleared Feb 25, 1998
ECHOLINK
K980060 · LLZ
Mpacs, LLC
Radiology · 49d
Cleared Feb 25, 1998
VITROS CHEMISTRY PRODUCTS CRBM SLIDES
K980283 · KLT
Johnson & Johnson Clinical...
Chemistry · 30d
Cleared Feb 25, 1998
LIQUICHEK CARDIAC MARKERS CONTROL LT
K980556 · JJT
Bio-Rad
Chemistry · 12d
Cleared Feb 24, 1998
VACUTAINER BRAND PPT PLASMA PREPARATION TUBE
K972075 · PJE
Becton Dickinson Vacutainer Systems
Chemistry · 266d
Cleared Feb 24, 1998
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K972145 · DHN
Immuno Concepts, Inc.
Immunology · 263d
Cleared Feb 24, 1998
DYNEMO 3000
K972798 · DPW
Sometec, Inc.
Radiology · 211d