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
157441–157464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1983
COUPLING/VALVE
K830399 · BTC
Khi, Inc.
Anesthesiology · 31d
Cleared Mar 10, 1983
LBI-100 37DEGREES INCUBATOR
K830405 · JTQ
Bionetic Laboratory Products
Chemistry · 31d
Cleared Mar 10, 1983
ICY COLD ICE CAP
K830416 · IME
Ladora Ent.
Physical Medicine · 30d
Cleared Mar 10, 1983
TACTAID
K830418 · LRA
Audiological Engineering Corp.
Ear, Nose, Throat · 30d
Cleared Mar 10, 1983
OTICON, E25P
K830435 · ESD
Octicon Corp.
Ear, Nose, Throat · 29d
Cleared Mar 10, 1983
OTICON, E-27P
K830436 · ESD
Octicon Corp.
Ear, Nose, Throat · 29d
Cleared Mar 10, 1983
LATERAL POSITIONING ATTACHMENT
K830443
Berivon Co.
Physical Medicine · 28d
Cleared Mar 10, 1983
ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
K830479 · DKN
Hoffmann-La Roche, Inc.
Toxicology · 23d
Cleared Mar 10, 1983
LIQUID OXYGEN SYSTEM
K830498 · BYJ
Puritan Bennett Corp.
Anesthesiology · 22d
Cleared Mar 10, 1983
LIC TILT BED
K830633 · INQ
Century Manufacturing Co.
Physical Medicine · 9d
Cleared Mar 09, 1983
SURE-COUNT DISPOSABLE NEEDLE COUNTER
K822735 · MMK
Geneva Laboratories, Inc.
General Hospital · 181d
Cleared Mar 09, 1983
URINARY BLADDER TEMP. SENSOR #81-003
K823077 · FLL
Clinical Technology Corp.
General Hospital · 141d
Cleared Mar 09, 1983
ENDOMED 433
K823362
Kipp & Zonen
Physical Medicine · 120d
Cleared Mar 09, 1983
ALES
K823385 · HPG
Oms
Ophthalmic · 114d
Cleared Mar 09, 1983
P-S CSF-VENTRICULAR CATHETER, FLANGED
K823503 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 105d
Cleared Mar 09, 1983
SPECTRON PROXIMAL FEMORAL PROSTHESIS
K823723 · JDI
Richard'S Medical Equip., Inc.
Orthopedic · 89d
Cleared Mar 09, 1983
SPECTRON NECK REPLACEMENT PROSTHESIS
K823724 · JDI
Richard'S Medical Equip., Inc.
Orthopedic · 89d
Cleared Mar 09, 1983
SPECTRON CONVERSION ENDOPROSTHESIS CUP
K823726 · KWY
Richard'S Medical Equip., Inc.
Orthopedic · 89d
Cleared Mar 09, 1983
HANDI-WASH
K823787 · LIB
Dynatech Corp.
Chemistry · 83d
Cleared Mar 09, 1983
COVER-ROLL STRETCH
K823879 · NAB
Beiersdorf, Inc.
General & Plastic Surgery · 72d
Cleared Mar 09, 1983
BACTIGEN-N. MENINGITIDIS
K823880 · GTJ
Armkel, LLC
Microbiology · 72d
Cleared Mar 09, 1983
TELEMETRY SYSTEM
K823906 · DRG
Transkinetic Systems, Inc.
Cardiovascular · 71d
Cleared Mar 09, 1983
ARTEC TWIST VALVE
K830056 · BTC
Artec Environmental Monitoring Division
Anesthesiology · 62d
Cleared Mar 09, 1983
ENDECO ACOUSTIC OTOSCOPE
K830139 · ETY
Endeco Medical, Inc.
Ear, Nose, Throat · 55d