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
97897–97920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1996
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
K961226 · CJY
Johnson & Johnson Clinical...
Chemistry · 39d
Cleared May 07, 1996
KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME
K961244 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 36d
Cleared May 07, 1996
AUDIO 'D' INTIMA CIC
K961308 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 33d
Cleared May 07, 1996
HM-88011 SOLID STATE ELECTR SURGICAL UNIT
K961473 · GEI
Hill-Med, Inc.
General & Plastic Surgery · 20d
Cleared May 07, 1996
BCW ADVANTAGE WHEELCHAIR
K961514 · IOR
Wheelchairs of Kansas
Physical Medicine · 18d
Cleared May 06, 1996
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · LSL
Abbott Laboratories
Microbiology · 881d
Cleared May 06, 1996
THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
K955282 · FMF
Thermogenesis Corp.
General Hospital · 172d
Cleared May 06, 1996
OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH...
K955332 · DZE
Opti-Max
Dental · 168d
Cleared May 06, 1996
SNAPDOSE DEVICE
K955410 · FPA
Abbott Laboratories
General Hospital · 161d
Cleared May 06, 1996
COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
K960178 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 111d
Cleared May 06, 1996
VITAFLOW SUCTION/ASPIRATION TUBING SET
K960616 · BYY
Vital Concepts, Inc.
General Hospital · 83d
Cleared May 06, 1996
CERTI COOL INSTANT COLD COMPRESS
K960624 · IMD
Certified Safety Mfg., Inc.
Physical Medicine · 83d
Cleared May 06, 1996
BARBITURATE SERUM TOX EIA ASSAY
K960664 · DIS
Diagnostic Reagents, Inc.
Toxicology · 80d
Cleared May 06, 1996
ULTRACID AND ULTRACID F DISINFECTING SOLUTION
K960697 · KLE
Ultradent Products, Inc.
Dental · 76d
Cleared May 06, 1996
CORD WRAP WITH NEEDLE RESHEATHER
K960963 · FMI
Osborn Medical Corp.
General Hospital · 56d
Cleared May 06, 1996
SARGON IMMEDIATE LOAD IMPLANT
K961005 · DZE
Graham & James
Dental · 55d
Cleared May 06, 1996
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
K961043 · JKR
Scantibodies Laboratory, Inc.
Chemistry · 53d
Cleared May 06, 1996
POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133
K961474 · FPA
Medtronic Minimed
General Hospital · 18d
Cleared May 03, 1996
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
K950484 · CBK
Bird Products Corp.
Anesthesiology · 452d
Cleared May 03, 1996
IMMUNO DOT BORRELIA DOT BLOT G TEST
K953682 · LSR
Genbio
Microbiology · 270d
Cleared May 03, 1996
MMUNO DOT BORRELIA DOT BLOT M TEST
K953683 · LSR
Genbio
Microbiology · 270d
Cleared May 03, 1996
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES
K954221 · LYY
Hartalega Sdn Bhd
General Hospital · 235d
Cleared May 03, 1996
BURDICK 200 PULSE OXIMETER
K954267 · DQA
Burdick, Inc.
Anesthesiology · 234d
Cleared May 03, 1996
OPTIBLAST INTRAORAL SANDBLASTER
K955573 · KOJ
Buffalo Dental Mfg. Co., Inc.
Dental · 148d