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
75241–75264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2002
MICROJET CRONO PCA
K013822 · MEA
Cane S.R.L.
General Hospital · 173d
Cleared May 08, 2002
PADPRO MODEL #2516
K020203 · MKJ
Padpro, LLC
Cardiovascular · 106d
Cleared May 08, 2002
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD
K020313 · DKZ
Acon Laboratories Co.
Toxicology · 98d
Cleared May 08, 2002
SYNTHES CALCANEAL PLATE
K020401 · HRS
Synthes (Usa)
Orthopedic · 90d
Cleared May 08, 2002
HEC 1000
K020466 · KPJ
Metro Medical Equipment, Inc.
General & Plastic Surgery · 85d
Cleared May 08, 2002
MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K020634 · DXE
Atrium Medical Corp.
Cardiovascular · 70d
Cleared May 08, 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
K020723 · JIT
Dade Behring, Inc.
Chemistry · 63d
Cleared May 08, 2002
WILSON-COOK ZILVER BILIARY STENT
K020788 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 58d
Cleared May 08, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
K020822 · JWY
Dade Behring, Inc.
Microbiology · 56d
Cleared May 08, 2002
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845 · DLJ
Dade Behring, Inc.
Toxicology · 54d
Cleared May 08, 2002
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
K020865 · LYY
Apl Products Sdn. Bhd.
General Hospital · 51d
Cleared May 08, 2002
PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
K021065 · KGO
Primus Gloves Private , Ltd.
General Hospital · 36d
Cleared May 08, 2002
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
K021090 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 34d
Cleared May 08, 2002
DM SLEEVE
K021102 · DWL
Emily Iker M.D., A.P.C.
General Hospital · 34d
Cleared May 08, 2002
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
K021148 · MNH
Depuyacromed
Orthopedic · 28d
Cleared May 08, 2002
Q-STRESS ECHO BED
K021171 · DPS
Medical Positioning, Inc.
Cardiovascular · 26d
Cleared May 08, 2002
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
K021300 · DSI
Philips Medical Systems
Cardiovascular · 14d
Cleared May 08, 2002
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
K021410 · ELW
Dentsply Intl.
Dental · 5d
Cleared May 07, 2002
STEAM STERILIZATION INTERGRATOR
K012195 · JOJ
Dana Products, Inc.
General Hospital · 298d
Cleared May 07, 2002
MAINSTREAM WATER PURIFICATION DEVICE
K012716 · NHV
Prismedical Corp.
Gastroenterology & Urology · 265d
Cleared May 07, 2002
HIGH SILVER CONVENTIONAL
K020452 · EJJ
Ab Ardent
Dental · 85d
Cleared May 07, 2002
SULTAN SPOROX TEST VIAL, MODEL 75195
K020612 · JOJ
Sultan Chemists, Inc.
General Hospital · 71d
Cleared May 07, 2002
OSSIFORM
K020720 · LYC
Unicare Biomedical, Inc.
Dental · 63d
Cleared May 07, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
K021251 · DSI
Philips Medical Systems
Cardiovascular · 18d