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
70633–70656 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2003
VIEWPOINT TELEMETRY SYSTEM
K031760 · MHX
Datascope Corp.
Cardiovascular · 126d
Cleared Oct 10, 2003
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT),...
K031797 · DJR
Lin-Zhi International, Inc.
Toxicology · 122d
Cleared Oct 10, 2003
CAREMATIX WELLNESS SYSTEM
K031840 · DXN
Carematix, Inc.
Cardiovascular · 116d
Cleared Oct 10, 2003
CARESTATION 126S VIDEOPHONE
K031863 · MWI
Motion Media Technology, Inc.
Cardiovascular · 116d
Cleared Oct 10, 2003
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
K031901 · JWH
Stelkast Company
Orthopedic · 112d
Cleared Oct 10, 2003
POWDER FREE VINYL EXAMINATION GLOVE
K032071 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 99d
Cleared Oct 10, 2003
NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
K032115 · JXI
Polyganics B.V.,
Neurology · 93d
Cleared Oct 10, 2003
RUBBERCARE POWDERED LATEX EXAMINATION GLOVES
K032201 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 84d
Cleared Oct 10, 2003
ONLINE TDM AMIKA
K032279 · KLP
Roche Diagnostics Corp.
Toxicology · 78d
Cleared Oct 10, 2003
FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR
K032290 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 78d
Cleared Oct 10, 2003
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
K032310 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 74d
Cleared Oct 10, 2003
KLS-MARTIN STERNAL PLATING SYSTEM
K032413 · HRS
KLS-Martin L.P.
Orthopedic · 66d
Cleared Oct 10, 2003
MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
K032467 · KGO
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 60d
Cleared Oct 10, 2003
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
K032471 · LHQ
Titronics Research & Development Co.
Radiology · 60d
Cleared Oct 10, 2003
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K032577 · DQK
Ge Medical Systems Information...
Cardiovascular · 50d
Cleared Oct 10, 2003
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
K032620 · IYN
General Electric Co.
Radiology · 45d
Cleared Oct 10, 2003
HL888BM
K032837 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
HL888BA
K032839 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS,...
K032858 · DSI
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Oct 10, 2003
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
K032881 · CDZ
Diagnostic Products Corp.
Chemistry · 25d
Cleared Oct 10, 2003
RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
K032924 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 18d
Cleared Oct 10, 2003
ACCUSONIC A-SCAN MODEL, 24-4000
K032956 · IYO
Accutome, Inc.
Radiology · 18d
Cleared Oct 10, 2003
BRM2 BRAIN MONITOR
K033010 · OLT
Brainz Instruments , Ltd.
Neurology · 14d
Cleared Oct 10, 2003
MODIFICATION TO HL168
K033043 · DXN
Health & Life Co., Ltd.
Cardiovascular · 11d