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
75049–75072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2002
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
K020628 · HHK
Bioteque America, Inc.
Obstetrics & Gynecology · 87d
Cleared May 24, 2002
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS...
K020642 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 86d
Cleared May 24, 2002
UNITY IS PATIENT VIEWER
K020661 · MSX
General Electric Medical Systems...
Cardiovascular · 84d
Cleared May 24, 2002
SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K020701 · NHW
Guidant Corporation, Cardiac Surgery
Cardiovascular · 81d
Cleared May 24, 2002
SPECTRAL'S 2 IN 1 (TNI-MYO)
K020950 · MMI
Spectral Diagnostics, Inc.
Chemistry · 60d
Cleared May 24, 2002
G4 SLEEVED NAIL
K020962 · HSB
Biomet Manufacturing, Inc.
Orthopedic · 60d
Cleared May 24, 2002
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
K021344 · EOQ
Vision-Sciences, Inc.
Ear, Nose, Throat · 25d
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