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
85393–85416 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1999
SKIN 2 FORTE SILICONE SHEETING
K990651 · MDA
United Hospital Technologies, Inc.
General & Plastic Surgery · 165d
Cleared Aug 13, 1999
CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
K990724 · GCJ
Conway Stuart Medical, Inc.
General & Plastic Surgery · 161d
Cleared Aug 13, 1999
PARAMED PARAFFIN WARMER
K991427 · IMC
Divi Intl. Co.
Physical Medicine · 112d
Cleared Aug 13, 1999
HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
K991685 · CAF
Medic-Aid , Ltd.
Anesthesiology · 88d
Cleared Aug 13, 1999
EBI OMEGA 21 SYSTEM
K991721 · MNI
Ebi Electro Biology
Orthopedic · 85d
Cleared Aug 13, 1999
DIGITAL VIDEO RECORDING SYSTEM
K991738 · LLZ
Kay Elemetrics Corp.
Radiology · 84d
Cleared Aug 13, 1999
ENDOSCOPIC SPINAL ACCESS SYSTEM
K991794 · HRX
Endius, Inc.
Orthopedic · 79d
Cleared Aug 13, 1999
EXPLORER 3D
K991815 · MUJ
Our Scientific Intl., Inc.
Radiology · 78d
Cleared Aug 13, 1999
PARALLAX TRACER RADIOPAQUE PARTICLES
K991893 · MYU
Parallax Medical, Inc.
Neurology · 71d
Cleared Aug 13, 1999
INTERMITTENT COMPRESSION BOOT FOR OTC
K991921 · IRP
Eischoco, Inc.
Physical Medicine · 67d
Cleared Aug 13, 1999
KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
K991958 · LJL
Kiel Laboratories, Inc.
General Hospital · 64d
Cleared Aug 13, 1999
SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE...
K991960 · GEI
Stryker Endoscopy
General & Plastic Surgery · 64d
Cleared Aug 13, 1999
INFANT FLOW SYSTEM
K991972 · BZD
Sensor Medics Corp.
Anesthesiology · 63d
Cleared Aug 13, 1999
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
K992025 · MEH
Howmedica Osteonics Corp.
Orthopedic · 58d
Cleared Aug 13, 1999
SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM
K992046 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Aug 13, 1999
DYNAWELL OR DYNAWELL
K992120 · LNH
Ekeroth Quality AB
Radiology · 51d
Cleared Aug 13, 1999
MONARCH II MINI MASK
K992336 · BZD
Respironics, Inc.
Anesthesiology · 31d
Cleared Aug 13, 1999
NORODYN 8000 SEMG SYSTEM, ND-8000
K992439 · HCC
Myotronics-Noromed, Inc.
Neurology · 22d
Cleared Aug 13, 1999
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462 · LZN
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Aug 12, 1999
THERADYNE ROVER POWERED WHEELCHAIR
K982724 · ITI
Kurt Mfg. Co.
Physical Medicine · 372d
Cleared Aug 12, 1999
NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847
K982969 · CCK
Nonin Medical, Inc.
Anesthesiology · 352d
Cleared Aug 12, 1999
FETALGARD 3000 FETAL MONITOR
K983395 · HGM
Analogic Corp.
Obstetrics & Gynecology · 321d
Cleared Aug 12, 1999
RIWO DRIVE GENERATOR
K984304 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 253d
Cleared Aug 12, 1999
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
K984567 · MYA
Ventana, Inc.
Pathology · 232d