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
82177–82200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 02, 2000
SHELHIGH NO-REACT DURA SHIELD
K982101 · GXQ
Shelhigh, Inc.
Neurology · 687d
Cleared May 02, 2000
CEDIA DAU AMPHASSURE ASSAY
K994380 · DKZ
Microgenics Corp.
Toxicology · 127d
Cleared May 01, 2000
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
K000506 · MAI
Arthrex, Inc.
Orthopedic · 76d
Cleared May 01, 2000
MACROPRO GEL
K000518 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 75d
Cleared May 01, 2000
GLUCANPRO
K000519 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 75d
Cleared May 01, 2000
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000682 · KTT
Synthes (Usa)
Orthopedic · 62d
Cleared May 01, 2000
A100 AESTHETIC DIODE LASER
K000982 · GEX
Diomed, Inc.
General & Plastic Surgery · 35d
Cleared May 01, 2000
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
K001079 · ILJ
Arjo, Inc.
Physical Medicine · 27d
Cleared May 01, 2000
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
K001085 · DQA
Nonin Medical, Inc.
Anesthesiology · 27d