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
105721–105744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 1994
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K943739 · DQO
Mallinckrodt Medical
Cardiovascular · 105d
Cleared Nov 15, 1994
ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER
K943954 · HIF
Conmedcorp
Obstetrics & Gynecology · 92d
Cleared Nov 15, 1994
PROCHEQ 1 & 2
K944059 · JJY
Prisma Systems
Toxicology · 88d
Cleared Nov 15, 1994
COMPASS SOFTWARE MODULE
K944097 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 85d
Cleared Nov 15, 1994
DYNABITE LAPAROSCOPIC FORCEPS
K944245 · HET
Portlyn Corp.
Obstetrics & Gynecology · 77d
Cleared Nov 15, 1994
SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL...
K944292 · OCW
Surgical Innovations Corp.
Gastroenterology & Urology · 74d
Cleared Nov 15, 1994
DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET
K944338 · JJX
Casco Standards
Chemistry · 70d
Cleared Nov 15, 1994
LITE-BLADE
K944428 · CCW
Eare Consulting Service
Anesthesiology · 64d
Cleared Nov 15, 1994
DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER
K944435 · OCW
Deroyal Industries, Inc.
Gastroenterology & Urology · 64d
Cleared Nov 15, 1994
DMA IRON PROCEDURE
K944462 · JIY
Data Medical Associates, Inc.
Toxicology · 64d
Cleared Nov 15, 1994
OPTICAL FRAMES AND SUNGLASSES
K944526 · HQY
Aprilia Eyewear S.P.A.
Ophthalmic · 61d
Cleared Nov 15, 1994
DOCUMENTR AMMONIA/ETHANOLCALIBRATOR
K944639 · JIX
Casco Standards
Chemistry · 55d
Cleared Nov 15, 1994
SUNGLASSES AND SPECTACLE FRAMES
K944644 · HQY
Hung Wai Metal Manufactory
Ophthalmic · 55d
Cleared Nov 15, 1994
OCL CONTOUR
K945035 · DXQ
M-Pact Worldwide, LLC
Cardiovascular · 33d
Cleared Nov 14, 1994
SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.
K931021 · IYO
Shimadzu Medical Systems
Radiology · 623d
Cleared Nov 14, 1994
CONTINUOUS CARDIAC OUTPUT SYSTEM
K932414 · DXG
Abbott Laboratories
Cardiovascular · 544d
Cleared Nov 14, 1994
DATEX AS/3 TM ANAESTHESIA MONITOR
K933285 · BSZ
Datex Division Instrumentarium Corp.
Anesthesiology · 496d
Cleared Nov 14, 1994
MODULAR CERAMIC FEMORAL HEAD
K936256 · LZO
Stelkast Company
Orthopedic · 319d
Cleared Nov 14, 1994
ULTRASOUND PROBE DRAPE
K940151 · IYO
Hydro-Med Products, Inc.
Radiology · 315d
Cleared Nov 14, 1994
JBS SMOOTH FIXATION PIN
K940666 · HTY
J.B.S., S.A.
Orthopedic · 271d
Cleared Nov 14, 1994
J.B.S. B.A.C. PIN
K940669 · HTY
J.B.S., S.A.
Orthopedic · 271d
Cleared Nov 14, 1994
J.B.S. SELF-TAPPING THREADED PIN
K940673 · HTY
J.B.S., S.A.
Orthopedic · 271d
Cleared Nov 14, 1994
PPM III
K940712 · CBP
O-Two Systems Intl., Inc.
Anesthesiology · 270d
Cleared Nov 14, 1994
NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)
K941167 · DXN
Spacelabs Medical, Inc.
Cardiovascular · 245d