Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
142633–142656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1986
BARD IRYFIX(TM) STOMA CAP
K862631 · EXB
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared Oct 16, 1986
COMMVIEW SYSTEM
K862715 · LMD
A T & T Technologies, Inc.
Radiology · 91d
Cleared Oct 16, 1986
HYDRO-CLENZ UNIT
K863539 · KPL
Atlantic Health Group
Gastroenterology & Urology · 35d
Cleared Oct 16, 1986
GSC 1000
K863566 · JJQ
Genetic Systems Corp.
Chemistry · 34d
Cleared Oct 16, 1986
CHLORIDE PROCEDURE
K863585 · CHJ
Data Medical Associates, Inc.
Chemistry · 31d
Cleared Oct 16, 1986
SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS
K863631 · KPO
American Healthcare Corp.
Gastroenterology & Urology · 29d
Cleared Oct 16, 1986
SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES
K863633 · LDQ
Biological & Environmental Control...
General & Plastic Surgery · 29d
Cleared Oct 16, 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
K863678 · CGJ
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Oct 16, 1986
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · CEP
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Oct 16, 1986
CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM
K863830 · EZQ
Coloplast A/S
Gastroenterology & Urology · 16d
Cleared Oct 16, 1986
ACID PHOSPHATASE (ACP) REAGENT
K863851 · CKB
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared Oct 15, 1986
COMFORTRON
K862092 · KZM
M. D. Supply, Inc.
Dental · 135d
Cleared Oct 15, 1986
EXACTECH TOTAL HIP SYSTEM
K862234 · JDI
Exactech, Inc.
Orthopedic · 126d
Cleared Oct 15, 1986
BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE
K862238 · BTR
Bivona Medical Technologies
Anesthesiology · 125d
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