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
75289–75312 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012634 · KTW
Alliance Medical, Inc.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K012645 · KTW
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
K012648 · KTT
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
GLUCOPRO EVO INFUSION PUMP
K013309 · LZG
Nipro Diabetes Systems, Inc.
General Hospital · 263d
Cleared Jun 24, 2002
CARDEON AEGIS CATHETER
K013593 · DWF
Cardeon Corp.
Cardiovascular · 237d
Cleared Jun 24, 2002
TANITA BODY COMPOSITION ANALYZER
K014009 · MNW
Tanita Corp. of America
Gastroenterology & Urology · 201d
Cleared Jun 24, 2002
CHOLESTEROL 1, 2, 3
K014018 · LBS
Imi
Chemistry · 200d
Cleared Jun 24, 2002
CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT
K020205 · FRC
Getinge/Castle, Inc.
General Hospital · 153d
Cleared Jun 24, 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · FMF
Baxter Healthcare Corp
General Hospital · 115d
Cleared Jun 24, 2002
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6...
K020996 · NGT
Medefil, Inc.
General Hospital · 88d
Cleared Jun 24, 2002
SUBDURAL STRIP ELECTRODE
K021144 · GYC
Nicolet Biomedical, Inc.
Neurology · 76d
Cleared Jun 24, 2002
M2376 DEVICELINK SYSTEM
K021912 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 13d
Cleared Jun 24, 2002
MEDICA EASYQC HEMATOCRIT CONTROL
K021924 · GLK
Bionostics, Inc.
Hematology · 13d
Cleared Jun 21, 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 217d
Cleared Jun 21, 2002
QUPID PLUS E.R.
K020378 · JHI
Stanbio Laboratory
Chemistry · 136d
Cleared Jun 21, 2002
CANDELA CBEAM PULSED DYE LASER SYSTEM
K020958 · GEX
Candela Corp.
General & Plastic Surgery · 88d
Cleared Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980 · JIT
Dade Behring, Inc.
Immunology · 87d
Cleared Jun 21, 2002
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
K021043 · GAL
Gramsmed, LLC
General & Plastic Surgery · 81d
Cleared Jun 21, 2002
CINESCAN S
K021683 · IYO
Quantel Medical
Radiology · 30d
Cleared Jun 21, 2002
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45...
K021701 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 29d
Cleared Jun 21, 2002
HORIZONS HOT BIOPSY FORCEPS
K021706 · KGE
Horizons Intl. Corp.
Gastroenterology & Urology · 29d
Cleared Jun 21, 2002
RT-PLUS PE INSERT CLAMP
K021714 · KRO
Plus Orthopedics
Orthopedic · 28d
Cleared Jun 21, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K021729 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 21, 2002
VISUCAM
K021787 · NFF
Carl Zeiss Ophthalmic Systems, Inc.
Ophthalmic · 22d