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
74833–74856 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2002
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
K021472 · IPF
Home Medical Services
Physical Medicine · 90d
Cleared Aug 06, 2002
BRESAGEN CATHETER, MODEL CS-3000
K021481 · HCA
Bresagen, Inc.
Neurology · 90d
Cleared Aug 06, 2002
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
K021496 · GZJ
Home Medical Services
Neurology · 89d
Cleared Aug 06, 2002
CYTOFLEX MESH
K021511 · JEY
Unicare Biomedical, Inc.
Dental · 89d
Cleared Aug 06, 2002
ADC DENTAL
K021542 · MUH
Agfa Corp.
Radiology · 88d
Cleared Aug 06, 2002
PERF (OMMAYA STYLE) RESERVOIRS
K021644 · JXG
Phoenix Biomedical Corp.
Neurology · 78d
Cleared Aug 06, 2002
CRYOBAG, MODEL CB
K021702 · LPZ
Origen Biomedical, Inc.
General Hospital · 75d
Cleared Aug 06, 2002
E-CARE INFARED EAR THERMOMETER, MODEL LCT-200
K021753 · FLL
E-Care Technology Corporation
General Hospital · 69d
Cleared Aug 06, 2002
MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
K021974 · MRZ
Minimed, Inc.
General Hospital · 50d
Cleared Aug 06, 2002
F 900
K022054 · HKY
C.S.O. S.R.L.
Ophthalmic · 43d
Cleared Aug 06, 2002
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
K022065 · JEC
Sintea Biotech, Inc.
Orthopedic · 42d
Cleared Aug 06, 2002
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
K022209 · FPA
Alaris Medical Systems, Inc.
General Hospital · 29d
Cleared Aug 06, 2002
MOBILE MILLENNIUM MG SYSTEM
K022240 · KPS
Ge Medical Systems, Inc.
Radiology · 26d
Cleared Aug 06, 2002
STRYKER L3 HYDROLERT
K022248 · FLN
Stryker Endoscopy
General Hospital · 25d
Cleared Aug 06, 2002
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
K022281 · DTN
Polystan A/S
Cardiovascular · 22d
Cleared Aug 06, 2002
BLACKSTONE SPINAL FIXATION SYSTEM SPACER
K022399 · KWQ
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared Aug 06, 2002
SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K022400 · IYN
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Aug 06, 2002
QUANTITATIVE BLOOD POOL SPECT (QBS)
K022428 · LLZ
Adac Laboratories
Radiology · 12d
Cleared Aug 05, 2002
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
K001755 · FIP
Mpw Industrial Water Services, Inc.
Gastroenterology & Urology · 787d
Cleared Aug 05, 2002
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
K013704 · KLA
Mediplus , Ltd.
Gastroenterology & Urology · 270d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672 · JZO
Roche Diagnostics Corp.
Immunology · 157d
Cleared Aug 05, 2002
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
K021357 · HPZ
Porex Surgical, Inc.
Ophthalmic · 98d
Cleared Aug 05, 2002
POLY STAT HCG DIPSTICK TEST
K021386 · JHI
Alidex, Inc.
Chemistry · 95d
Cleared Aug 05, 2002
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS...
K021855 · LYY
Top Glove Sdn. Bhd.
General Hospital · 60d