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
83617–83640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1999
CLEARPLAN EASY II HOME PREGNANCY TEST
K993333 · LCX
Unipath , Ltd.
Chemistry · 73d
Cleared Dec 16, 1999
PALL SUPOR AEF FILTER
K993379 · FPB
Pall Corp.
General Hospital · 70d
Cleared Dec 16, 1999
WAKO L-TYPE GOT TEST
K993468 · CIT
Wako Chemicals USA, Inc.
Chemistry · 64d
Cleared Dec 16, 1999
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
K993571 · CDD
Bayer Corp.
Chemistry · 56d
Cleared Dec 16, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC...
K993711 · JZG
Bayer Corp.
Chemistry · 43d
Cleared Dec 16, 1999
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
K993764 · KCT
Medipack Medical Packaging Mfg. Co.
General Hospital · 38d
Cleared Dec 16, 1999
PARAPOST SYSTEM STERILIZABLE ORGANIZER
K993835 · FRG
Coltene/Whaledent, Inc.
General Hospital · 34d
Cleared Dec 16, 1999
AVL OPTI CRITICAL CARE ANALYZER
K993837 · CGA
Avl Scientific Corp.
Chemistry · 34d
Cleared Dec 16, 1999
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952 · LFZ
Diagnostic Products Corp.
Microbiology · 24d
Cleared Dec 16, 1999
AT WORK DRUG TEST, MODEL 9145-25C
K994093 · LCL
Phamatech
Toxicology · 13d
Cleared Dec 15, 1999
QMS MAPPING SYSTEM,MODEL 2000
K990058 · DQK
Cathdata, Inc.
Cardiovascular · 342d
Cleared Dec 15, 1999
ATR 3000, ATR 2000, IMPLANT-PRO
K991401 · EFB
Advanced Technology Research (A.T.R.)...
Dental · 237d
Cleared Dec 15, 1999
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K992631 · DQO
Acuson Corp.
Radiology · 131d
Cleared Dec 15, 1999
BREMER HALO SYSTEM TITANIUM SKULL PIN
K993099 · JEC
Depuyacromed
Orthopedic · 90d
Cleared Dec 15, 1999
TRIP TONOMETRY CATHETER, 14F
K993296 · KNT
Datex-Ohmeda, Inc.
Gastroenterology & Urology · 75d
Cleared Dec 15, 1999
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
K993413 · ITI
Invacare Corp.
Physical Medicine · 64d
Cleared Dec 15, 1999
BACT/ALERT SA
K993423 · MDB
Organon Teknika Corp.
Microbiology · 64d
Cleared Dec 15, 1999
SYSTEM 2100
K993530 · LLZ
Math Solutions, LLC
Radiology · 58d
Cleared Dec 15, 1999
DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST...
K993532 · LLZ
Impax Technology, Inc.
Radiology · 57d
Cleared Dec 15, 1999
DCI ENDOSCOPE
K993539 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 57d
Cleared Dec 15, 1999
CONFORMAX MMLC VR1
K993594 · IYE
Radionics, Inc.
Radiology · 51d
Cleared Dec 15, 1999
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617
K993597 · LMA
Vidar Systems Corp.
Radiology · 51d
Cleared Dec 15, 1999
PRE-VISION FILL
K993602 · EBF
Heraeus Kulzer, Inc.
Dental · 51d
Cleared Dec 15, 1999
OMNISONICS ULTRASONIC PROBES
K993628 · LFL
Omnisonics Medical Technologies
General & Plastic Surgery · 49d