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
92857–92880 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1997
PHONAK NOVO FORTE E3
K972106 · ESD
Phonak, Inc.
Ear, Nose, Throat · 71d
Cleared Aug 15, 1997
MINIMED INFUSION PUMP, MODEL 507C
K972107 · LZG
Medtronic Minimed
General Hospital · 71d
Cleared Aug 15, 1997
VERA PDN
K972118 · EJH
Aalba Dent, Inc.
Dental · 71d
Cleared Aug 15, 1997
DEVMED STEPPING AND STABILIZING SYSTEM
K972152 · ITX
Devmed Corp.
Radiology · 67d
Cleared Aug 15, 1997
MEDI-SIS SYRINGE INFUSION SYSTEM
K972173 · MEB
I-Flow Corp.
General Hospital · 67d
Cleared Aug 15, 1997
CEREC 2 CROWN SOFTWARE
K972276 · ELW
Siemens AG
Dental · 58d
Cleared Aug 15, 1997
IL TEST IRON
K972363 · JIY
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Aug 15, 1997
SEALAPEX
K972369 · KIF
Sybron Dental Specialties, Inc.
Dental · 51d
Cleared Aug 15, 1997
ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM
K972465 · IYN
Aloka Co., Ltd.
Radiology · 45d
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