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
104377–104400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1995
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
K945514 · LCX
Princeton BioMeditech Corp.
Chemistry · 93d
Cleared Feb 10, 1995
BLADE ELECTRODE
K945531 · GEI
E & M Engineering, Inc.
General & Plastic Surgery · 88d
Cleared Feb 10, 1995
DISPOSABLE 1CC SYRINGE WITH LUER LOCK
K945588 · FMF
Interventional Therapeutics Corp.
General Hospital · 88d
Cleared Feb 10, 1995
APPLIED MEDICAL OPTICAL VALVULOTOME
K945591 · LYK
Applied Medical Resources
Cardiovascular · 88d
Cleared Feb 10, 1995
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
K945608 · DJG
Princeton BioMeditech Corp.
Toxicology · 87d
Cleared Feb 10, 1995
ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS
K945966 · JIX
Alko Diagnostic Corp.
Chemistry · 65d
Cleared Feb 10, 1995
LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2
K946048 · JZG
Clinical Controls, Inc.
Immunology · 60d
Cleared Feb 10, 1995
LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2
K946049 · JJY
Clinical Controls, Inc.
Chemistry · 60d
Cleared Feb 10, 1995
LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2
K946050 · DCK
Clinical Controls, Inc.
Immunology · 60d
Cleared Feb 10, 1995
PHENOBARBITAL ENZYME IMMUNOASSAY
K946210 · DLZ
Diagnostic Reagents, Inc.
Toxicology · 51d
Cleared Feb 10, 1995
FERRITIN CONTROL - LEVEL 1, 2, 3
K946266 · DGD
Clinical Controls, Inc.
Immunology · 49d
Cleared Feb 10, 1995
MEGABEAM FIBER OPTIC DELIVERY SYSTEM
K946336 · GEX
Hogan & Hartson
General & Plastic Surgery · 43d
Cleared Feb 10, 1995
BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B
K950051 · FMS
The Brewer Co.
General Hospital · 35d
Cleared Feb 10, 1995
MC HEALTHCARE #CH31 CHILD'S CRIB
K950058 · FMS
Janco Consulting Services
General Hospital · 35d
Cleared Feb 10, 1995
MC INFANT CARE UNIE #PP30
K950059 · FMS
Janco Consulting Services
General Hospital · 35d
Cleared Feb 10, 1995
PROVILINK
K950060 · EMA
Ivoclar North America, Inc.
Dental · 35d
Cleared Feb 10, 1995
THERASTEAM PERSONAL STEAM INHALER
K950116 · KFZ
Kaz, Inc.
Anesthesiology · 30d
Cleared Feb 10, 1995
VALLEYLAB COATED ELECTRODES
K950188 · GEI
Valleylab, Inc.
General & Plastic Surgery · 24d
Cleared Feb 10, 1995
CARDON PHYSICAL THERAPY TABLE MODEL R28535
K950360 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 11d
Cleared Feb 10, 1995
CARDON PHYSICAL THERAPY TABLE R28575
K950361 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 11d
Cleared Feb 10, 1995
CARDON PHYSICAL THERAPY TABLE R27114 AND R27642
K950362 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 11d
Cleared Feb 10, 1995
CARDONPHYSICAL THERAPY TABLE R27110
K950363 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 11d
Cleared Feb 10, 1995
CARDON PHYSICAL THERAPY TABLES R27635
K950364 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 11d
Cleared Feb 10, 1995
FLEXTITIP STYLETTE
K950380 · BSR
Polamedco, Inc.
Anesthesiology · 10d