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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142057–142080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1986
MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR
K862830 · BTL
Pneupac , Ltd.
Anesthesiology · 84d
Cleared Oct 15, 1986
OTICON I31 INITIALES HEARING AID
K862981 · ESD
Oticon Corp.
Ear, Nose, Throat · 69d
Cleared Oct 15, 1986
INHALATION AID
K863049 · BYP
Boehringer Ingelheim Pharmaceuticals,...
Anesthesiology · 64d
Cleared Oct 15, 1986
RESPIRONICS PROTECTEASY
K863171 · KGK
Respironics, Inc.
Anesthesiology · 58d
Cleared Oct 15, 1986
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
K863177 · DTL
Cordis Corp.
Cardiovascular · 58d
Cleared Oct 15, 1986
CSI LIQUID OXYGEN SYSTEM
K863556 · BYJ
Cryogenic Services, Inc.
Anesthesiology · 33d
Cleared Oct 15, 1986
MONAGHAN RVM, MODEL 760 AND 761
K863612 · BZQ
Monaghan Medical Corp.
Anesthesiology · 29d
Cleared Oct 15, 1986
C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS
K863628 · DCK
Technicon Instruments Corp.
Immunology · 28d
Cleared Oct 15, 1986
OXYGEN CONSERVATOR
K863657 · CCN
Salter Labs
Anesthesiology · 27d
Cleared Oct 15, 1986
FLOW INTERRUPTION INDICATOR
K863659 · CCN
Salter Labs
Anesthesiology · 27d
Cleared Oct 15, 1986
COMPANION OXYGEN SAVER
K863695 · NFB
Puritan Bennett Corp.
Anesthesiology · 23d
Cleared Oct 15, 1986
SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE
K863703 · CCK
Salter Labs
Anesthesiology · 22d
Cleared Oct 15, 1986
MYOLEX
K863730 · DDR
Orion Corp.
Immunology · 22d
Cleared Oct 15, 1986
MODEL A-1 OXYGEN ANALYZER
K863806 · CCL
Medical, Inc.
Anesthesiology · 15d
Cleared Oct 15, 1986
CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE)
K863863 · DSH
Cardionostics, Inc.
Cardiovascular · 12d
Cleared Oct 14, 1986
NEUROSCOPE SEEG
K861884 · GWO
Siegen Corp.
Neurology · 152d
Cleared Oct 14, 1986
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)
K862233 · KLI
Ciba Corning Diagnostics Corp.
Chemistry · 125d
Cleared Oct 14, 1986
MICROFILL PONTIC
K862546 · EBF
Kulzer, Inc.
Dental · 103d
Cleared Oct 14, 1986
DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
K863089 · GDY
Lifestream Int'L, Inc.
General & Plastic Surgery · 62d
Cleared Oct 14, 1986
PEAK OVULATION PREDICTOR
K863121 · NGE
Micron Technology, Inc.
Toxicology · 61d
Cleared Oct 14, 1986
MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL
K863479 · GWM
Medical Measurements, Inc.
Neurology · 35d
Cleared Oct 14, 1986
DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE
K863482 · GCY
Cardio Metrics, Inc.
General & Plastic Surgery · 35d
Cleared Oct 14, 1986
STAND, IRRIGATOR, STEEL, FOLDING
K863690
Brenner Metal Prod Corp.
General & Plastic Surgery · 25d
Cleared Oct 14, 1986
MODEL 709 BIPOLAR MICRO COAGULATOR
K863701 · GEI
Bergen Mfg.
General & Plastic Surgery · 21d