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
82681–82704 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2000
SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF...
K000745 · LYY
Tillotson Healthcare Corp.
General Hospital · 56d
Cleared May 03, 2000
DIMAX 2
K000771 · EHD
Planmeca Oy
Radiology · 55d
Cleared May 03, 2000
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
K000778 · GEI
Arthrocare Corp.
General & Plastic Surgery · 54d
Cleared May 03, 2000
POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS...
K000896 · KGO
Fitco Dipped Products Pvt., Ltd.
General Hospital · 44d
Cleared May 03, 2000
4631 DUO DELIVERY SYSTEM
K000966 · EIA
A-Dec, Inc.
Dental · 37d
Cleared May 03, 2000
4635 ASSISTANT'S INSTRUMENTATION
K000967 · EIA
A-Dec, Inc.
Dental · 37d
Cleared May 03, 2000
3181 DUO DELIVERY SYSTEM
K000968 · EIA
A-Dec, Inc.
Dental · 37d
Cleared May 03, 2000
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT...
K001057 · DSI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared May 03, 2000
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4
K001083 · HCG
Boston Scientific, Target
Neurology · 29d
Cleared May 03, 2000
IDS5 IMAGE DISPLAY SYSTEM
K001140 · LLZ
Sectra AB
Radiology · 23d
Cleared May 03, 2000
MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM
K001153 · HAW
Medtronic Surgical Navigation
Neurology · 23d
Cleared May 03, 2000
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
K001238 · JEY
Walter Lorenz Surgical, Inc.
Dental · 15d
Cleared May 03, 2000
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K991422 · LZA
Shen Wei (Usa), Inc.
General Hospital · 376d
Cleared May 03, 2000
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K993520 · FIP
Serv-A-Pure Co.
Gastroenterology & Urology · 198d
Cleared May 02, 2000
SONOS AIRES 600 (SA-600)
K000320 · IYO
Kpi Ultrasound, LLC
Radiology · 90d
Cleared May 02, 2000
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
K000327 · HKO
Visx, Incorporated
Ophthalmic · 90d
Cleared May 02, 2000
ACTIVE ELECTRODE MONITORING SYSTEM
K000480 · GEI
Electroscope, Inc.
General & Plastic Surgery · 78d
Cleared May 02, 2000
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
K000545 · GCJ
Applied Medical Resources
General & Plastic Surgery · 74d
Cleared May 02, 2000
KRONNER LOW PROFILE SCOPE HOLDER
K000663 · GCJ
Kronner Prototypes, Inc.
General & Plastic Surgery · 64d
Cleared May 02, 2000
TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K000665 · FOZ
Tfx Medical, Inc.
General Hospital · 64d
Cleared May 02, 2000
HELIODENT VARIO
K000672 · EHD
Sirona Dental Systems GmbH
Radiology · 64d
Cleared May 02, 2000
DIRECT TIBC KIT
K000781 · JMO
Reference Diagnostics, Inc.
Chemistry · 53d
Cleared May 02, 2000
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
K000900 · CHH
Elan Holdings, Inc.
Chemistry · 42d
Cleared May 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE...
K001266 · CGN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 12d