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
75745–75768 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
K020820 · JWY
Dade Behring, Inc.
Microbiology · 57d
Cleared May 09, 2002
VORTEX VALVED HOLDING CHAMBER
K020944 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 45d
Cleared May 09, 2002
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER
K021054 · LMC
Codonics, Inc.
Radiology · 38d
Cleared May 09, 2002
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
K021135 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 30d
Cleared May 09, 2002
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
K021166 · FDC
Acmi-Circon Corporation
Gastroenterology & Urology · 28d
Cleared May 09, 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 08, 2002
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
K012712 · MLO
Norav Medical , Ltd.
Cardiovascular · 267d
Cleared May 08, 2002
COMPRESSIBLE LIMB SLEEVE
K012979 · JOW
Medical Device Services, Inc.
Cardiovascular · 245d
Cleared May 08, 2002
QFLOW 500 PERFUSION MONITORING SYSTEM
K013376 · DPW
Hemedex Incorporated
Cardiovascular · 209d
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