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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
156049–156072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1983
TRENDO-SCOPE
K831995 · HCS
Gabriel Ent.
Neurology · 48d
Cleared Aug 08, 1983
NML-5010/5020 MULTI-DETECTOR SYSTEM
K832002 · JJJ
Nuclear Medical Laboratories, Inc.
Chemistry · 47d
Cleared Aug 08, 1983
ARGYLE YANKAVER SUCTION TUBE W/CONTROL
K832027 · JOL
Sherwood Medical Co.
General Hospital · 46d
Cleared Aug 08, 1983
MODEL 327T UNIPOLAR CARDIAC PULSE GEN
K832052 · DXY
Cook Pacemaker Corp.
Cardiovascular · 42d
Cleared Aug 08, 1983
EMIT ASSAY AND TOBRAMYCIN
K832055 · LDO
Syva Co.
Chemistry · 42d
Cleared Aug 08, 1983
EMIT AMD GENTAMICIN ASSAY
K832056 · LCD
Syva Co.
Chemistry · 42d
Cleared Aug 08, 1983
VENOUS CATHETER
K832064 · DQY
Cardio Search, Inc.
Cardiovascular · 42d
Cleared Aug 08, 1983
EMIT CAD QUINIDINE ASSAY FOR USE W/
K832096 · LBZ
Syva Co.
Chemistry · 40d
Cleared Aug 08, 1983
IMMULON SUBSTRATE REMOVAWELL STRIPS
K832117 · LIB
Dynatech Corp.
Chemistry · 39d
Cleared Aug 08, 1983
SELF-SEAL STERILIZATION POUCHES
K832128 · KCT
Medical Industries Packaging, Inc.
General Hospital · 38d
Cleared Aug 08, 1983
IMPROVED SILICATH SILICONE ELASTOMER
K832165 · KOD
Travenol Laboratories, S.A.
Gastroenterology & Urology · 34d
Cleared Aug 08, 1983
MULTI-TITER DISPENSER
K832203 · JTC
Hamilton Co.
Microbiology · 32d
Cleared Aug 08, 1983
EPINEED EPIDURAL CATHETER
K832232 · BSO
Terumo Medical Corp.
Anesthesiology · 28d
Cleared Aug 08, 1983
EPINEED EPIDURAL NEEDLE
K832233 · BSP
Terumo Medical Corp.
Anesthesiology · 28d
Cleared Aug 01, 1983
PIPETTE 12 CHANNEL
K831644 · JTC
Organon Teknika Corp.
Chemistry · 70d
Cleared Aug 01, 1983
CLINOVATIVE II DIAGNOSTIC KIT
K831837 · LCP
Pierce Chemical Co.
Hematology · 55d
Cleared Aug 01, 1983
PULSAR #B SINGLE CHANNEL TENS-PULSAR D
K831950 · GZJ
Spembly Medical , Ltd.
Neurology · 47d
Cleared Aug 01, 1983
PENTAX FD-34A DUODENOFIBERSCOPE
K832006 · FDT
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 39d
Cleared Aug 01, 1983
BRONCHO-FIBERSCOPE
K832010 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 39d
Cleared Aug 01, 1983
EMIT AED PHENYTOIN ASSAY
K832033 · DIP
Syva Co.
Chemistry · 39d
Cleared Aug 01, 1983
EMIT AAD THEOPHYLLINE ASSAY
K832034 · KLS
Syva Co.
Chemistry · 39d
Cleared Aug 01, 1983
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K832074 · HKP
CooperVision, Inc.
Ophthalmic · 34d
Cleared Aug 01, 1983
PHONIC EAR PE 467R-PE 461T
K832080 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 34d
Cleared Aug 01, 1983
PHONIC EAR PE 845PPC-D
K832081 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 34d