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
70705–70728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2003
SIROTORQUE L
K031584 · EBW
Sirona Dental Systems GmbH
Dental · 90d
Cleared Aug 19, 2003
MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S
K031917 · FPA
Medtronic Minimed
General Hospital · 57d
Cleared Aug 19, 2003
GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
K032010 · LZA
Pt. Wrp Buana Multicorpora
General Hospital · 50d
Cleared Aug 19, 2003
GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
K032011 · LZA
Pt. Wrp Buana Multicorpora
General Hospital · 50d
Cleared Aug 19, 2003
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
K032077 · LZA
Seal Polymer Industries Bhd.
General Hospital · 43d
Cleared Aug 19, 2003
PASCO MIC AND MIC/ID PANELS
K032259 · JWY
Bd Diagnostic Systems
Microbiology · 28d
Cleared Aug 19, 2003
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
K032335 · JJY
Medical Analysis Systems, Inc.
Chemistry · 21d
Cleared Aug 19, 2003
VAXCEL PORT, MODELS 45-336 AND 45-338
K032375 · LJT
Boston Scientific Corp
General Hospital · 18d
Cleared Aug 18, 2003
STERRAD 200 STERILIZER
K030429 · MLR
Advanced Sterilization Products
General Hospital · 189d
Cleared Aug 18, 2003
JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET
K030479 · FOZ
Jms North America Corp.
General Hospital · 186d
Cleared Aug 18, 2003
FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT
K030730 · CDZ
Diagnostics Biochem Canada, Inc.
Chemistry · 161d
Cleared Aug 18, 2003
BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
K031742 · DQA
Bci, Inc.
Anesthesiology · 75d
Cleared Aug 18, 2003
PEM 2400 PET SCANNER
K032063 · KPS
Pem Technologies
Radiology · 46d
Cleared Aug 18, 2003
BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE...
K032131 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Aug 18, 2003
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K032287 · JIX
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Aug 15, 2003
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
K023140 · BSO
Epimed International, Inc.
Anesthesiology · 329d
Cleared Aug 15, 2003
VPAP III
K030843 · BZD
Resmed, Ltd.
Anesthesiology · 151d
Cleared Aug 15, 2003
POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE...
K031157 · LZA
Qingdao Bestex Rubber & Plastic...
General Hospital · 126d
Cleared Aug 15, 2003
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
K031958 · FLL
Microlife Intellectual Property GmbH
General Hospital · 51d
Cleared Aug 15, 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
K032168 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 30d
Cleared Aug 15, 2003
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
K032369 · MHX
Ge Medical Systems Information...
Cardiovascular · 14d
Cleared Aug 15, 2003
NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007
K032372 · JAQ
Nucletron Corporation
Radiology · 14d
Cleared Aug 14, 2003
AUSAM TOTAL ALBUMIN ASSAY
K013643 · JIQ
Ausam Biotecthnologies, Inc.
Chemistry · 647d
Cleared Aug 14, 2003
MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K021560 · FIP
Ameriwater
Gastroenterology & Urology · 458d