FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90673–90696 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1998
BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT...
K980418 · LPL
Benz Research and Development Corp.
Ophthalmic · 24d
Cleared Feb 26, 1998
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
K971592 · ILJ
The Silcraft Corp.
Physical Medicine · 301d
Cleared Feb 26, 1998
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT...
K971593 · ILJ
The Silcraft Corp.
Physical Medicine · 301d
Cleared Feb 26, 1998
ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD
K972877 · FMF
Safety Syringes, Inc.
General Hospital · 206d
Cleared Feb 26, 1998
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
K972883 · FXX
Cypress Medical Products, Ltd.
General Hospital · 205d
Cleared Feb 26, 1998
ULTRASAFE MODEL T200 INJECTOR
K972900 · FMF
Safety Syringes, Inc.
General Hospital · 204d
Cleared Feb 26, 1998
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
K973000 · MSQ
Alimenterics, Inc.
Microbiology · 198d
Cleared Feb 26, 1998
PREVENT I
K973373 · INO
The Buzzz Corp.
Physical Medicine · 171d
Cleared Feb 26, 1998
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT...
K974492 · MLD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
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