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
74785–74808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 20, 2002
EQUATION FIXATION SYSTEM
K013962 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 199d
Cleared Jun 20, 2002
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
K020279 · MNI
Forex Corp.
Orthopedic · 143d
Cleared Jun 20, 2002
TIPOWER POWERDRIVE AND RIMPOWER X & SX
K020539 · ITI
Tisport
Physical Medicine · 121d
Cleared Jun 20, 2002
TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
K020639 · ITI
Tisport
Physical Medicine · 113d
Cleared Jun 20, 2002
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM
K020967 · CBZ
Terumo Cardiovascular Systems Corp.
Anesthesiology · 87d
Cleared Jun 20, 2002
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6...
K020999 · NGT
Medefil, Inc.
General Hospital · 84d
Cleared Jun 20, 2002
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
K021008 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 84d
Cleared Jun 20, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
K021184 · LTT
Dade Microscan, Inc.
Microbiology · 66d
Cleared Jun 20, 2002
NIVEOUS LIQUID DAM
K021613 · EIE
Shofu Dental Corp.
Dental · 35d