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
92353–92376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1997
AALBA GOLD SOLDER
K972532 · EJT
Aalba Dent, Inc.
Dental · 39d
Cleared Aug 15, 1997
SYRINGE NEEDLE REMOVER (S.N.R.)
K972536 · FMI
Post Medical, Inc.
General Hospital · 68d
Cleared Aug 15, 1997
VERA PD SOLDER
K972632 · EJT
Aalba Dent, Inc.
Dental · 32d
Cleared Aug 15, 1997
WILSON-COOK NEEDLE KNIFE PAPILLOTOME
K972674 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 15, 1997
QUANTIFY(901)
K972710 · JJW
Hematronix, Inc.
Chemistry · 25d
Cleared Aug 15, 1997
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K972782 · JHX
Dade Intl., Inc.
Chemistry · 21d
Cleared Aug 15, 1997
POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE...
K972838 · LZA
Absolute Synthetic Technologies...
General Hospital · 14d
Cleared Aug 14, 1997
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
K963073 · LDF
Harmac Medical Products, Inc.
Cardiovascular · 412d
Cleared Aug 14, 1997
HARMAC THERMODILUTION CATHETER
K963336 · DYG
Harmac Medical Products, Inc.
Cardiovascular · 412d
Cleared Aug 14, 1997
TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS
K964176 · GEI
Tecno Instruments (Usa), Inc.
General & Plastic Surgery · 300d
Cleared Aug 14, 1997
ELPHA 2000 CONTI
K964738 · KPI
Dan Med, Inc.
Gastroenterology & Urology · 274d
Cleared Aug 14, 1997
LASETTE
K965124 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 234d
Cleared Aug 14, 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K970241 · LPH
Depuy, Inc.
Orthopedic · 204d
Cleared Aug 14, 1997
TITANIUM SPINAL ROD SYSTEM
K970635 · KWQ
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 175d
Cleared Aug 14, 1997
THE CIRCULATOR BOOT
K971026 · DRN
Circulator Boot Corp.
Cardiovascular · 147d
Cleared Aug 14, 1997
AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD
K971540 · GEI
American Biosurgical, Inc.
General & Plastic Surgery · 108d
Cleared Aug 14, 1997
ORTHO DX NEUROMUSCULAR STIMULATOR
K971542 · IPF
Rehabilicare, Inc.
Physical Medicine · 108d
Cleared Aug 14, 1997
SCULPTURE
K971609 · LFL
Servizi Medico Estetici Italinai Srl.
General & Plastic Surgery · 105d
Cleared Aug 14, 1997
ACCU-PULSE CARBON DIOXIDE LASER SYSTEM
K971830 · GEX
Argus Photonics Group
General & Plastic Surgery · 90d
Cleared Aug 14, 1997
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER
K971879 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 14, 1997
AQUA SPRAY
K971941 · GEY
Boyd Industries, Inc.
General & Plastic Surgery · 79d
Cleared Aug 14, 1997
CONFOSCAN
K971953 · HJO
Tomey Corporation USA
Ophthalmic · 78d
Cleared Aug 14, 1997
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE...
K972054 · KPI
Empi
Gastroenterology & Urology · 73d
Cleared Aug 14, 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 72d