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
71209–71232 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2003
EP-WORKMATE WITH RPM SYSTEM
K032225 · DQK
Ep Medsystems
Cardiovascular · 30d
Cleared Aug 20, 2003
DESIGNS FOR VISION FIBEROPTIC LIGHT
K032283 · GDB
Designs For Vision, Inc.
Gastroenterology & Urology · 27d
Cleared Aug 19, 2003
NX SYSTEM
K030222 · DRG
American Telecare, Inc.
Cardiovascular · 209d
Cleared Aug 19, 2003
ADVISOR, MODEL 9200
K030407 · CCK
Bci, Inc.
Anesthesiology · 193d
Cleared Aug 19, 2003
MIRAGE VISTA MASK
K031047 · BZD
Resmed, Ltd.
Anesthesiology · 139d
Cleared Aug 19, 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 105d
Cleared Aug 19, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH...
K031433 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 105d
Cleared Aug 19, 2003
PITANGA
K031489 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 99d
Cleared Aug 19, 2003
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · MEA
Baxter Healthcare Corp
General Hospital · 92d
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