Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
76177–76200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2002
AT HOME OVULATION TEST, MODEL 9032
K021409 · CEP
Phamatech, Inc.
Chemistry · 21d
Cleared May 24, 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
K021498 · JJT
Bio-Rad
Chemistry · 15d
Cleared May 23, 2002
QUICKCLOT
K013390 · QSY
On Site Gas Systems, Inc.
General & Plastic Surgery · 220d
Cleared May 23, 2002
APATIGHT HA-BONE GRAFT SUBSTITUTE
K013960 · MQV
Cerabio, LLC
Orthopedic · 171d
Cleared May 23, 2002
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET,...
K014192 · MVO
Princeton BioMeditech Corp.
Toxicology · 153d
Cleared May 23, 2002
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · LDJ
Princeton BioMeditech Corp.
Toxicology · 153d
Cleared May 23, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020321 · LON
Becton, Dickinson & CO
Microbiology · 128d
Cleared May 23, 2002
STATUS HCG SERUM/URINE
K020439 · JHI
Princeton BioMeditech Corp.
Chemistry · 101d
Cleared May 23, 2002
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING...
K020587 · KRB
Pulsion Medical Systems AG
Cardiovascular · 90d
Cleared May 23, 2002
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020620 · KWQ
Blackstone Medical, Inc.
Orthopedic · 87d
Cleared May 23, 2002
FINESUN EMS STIMULATOR
K020684 · IPF
Finesun Worldwide Intl. Co., Ltd.
Physical Medicine · 80d
Cleared May 23, 2002
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
K020914 · JBP
Helena Laboratories
Hematology · 63d
Cleared May 23, 2002
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT...
K021286 · JAQ
Nucletron Corp.
Radiology · 30d
Cleared May 23, 2002
EBI DFS OPTIROM ELBOW FIXATOR
K021312 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared May 23, 2002
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
K021324 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 27d
Cleared May 22, 2002
AVEA
K013642 · CBK
Bird Products Corp.
Anesthesiology · 198d
Cleared May 22, 2002
ULTRAGARD IMPERVIOUS REINFORCED GOWN
K013846 · FYA
Precept Medical Products, Inc.
General Hospital · 183d
Cleared May 22, 2002
LATEX SURGEONS GLOVE (POWDER FREE)
K014283 · KGO
Brightway Gloves Pvt. , Ltd.
General Hospital · 146d
Cleared May 22, 2002
MEDCOMP ASH SPLIT-CATH II
K020465 · MSD
Medcomp
Gastroenterology & Urology · 99d
Cleared May 22, 2002
APPLIED URETERAL CATHETER
K020577 · EYB
Applied Medical Resources Corp.
Gastroenterology & Urology · 90d
Cleared May 22, 2002
N2000 BASE STATION
K020584 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 90d
Cleared May 22, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020600 · KWQ
Blackstone Medical, Inc.
Orthopedic · 89d
Cleared May 22, 2002
ORION NASAL CPAP SYSTEM
K020730 · BZD
Bird Products Corp.
Anesthesiology · 77d
Cleared May 22, 2002
IMAGINE H.E. PRESS DESIGN-CERAMIC
K020774 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 72d