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
137161–137184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1987
BONE CUTTING INSTRUMENTS & ACCESSORIES
K874961 · GDR
Solway, Inc.
General & Plastic Surgery · 28d
Cleared Dec 30, 1987
MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE
K874965 · HTD
Solway, Inc.
General & Plastic Surgery · 28d
Cleared Dec 30, 1987
ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM
K875021 · JDW
Buckman Co., Inc.
Orthopedic · 26d
Cleared Dec 29, 1987
QUIK-PACE NONINVASIVE PACEMAKER
K871751 · DRO
Physio-Control Corp.
Cardiovascular · 235d
Cleared Dec 29, 1987
COMBINATION NITE DRAINAGE UNIT
K872294 · EXB
Arnold Technologies
Gastroenterology & Urology · 196d
Cleared Dec 29, 1987
OMNIFIT DISTAL STEM CEMENT SPACERS
K872528 · JDK
Osteonics Corp.
Orthopedic · 187d
Cleared Dec 29, 1987
DUOFLO DISPENSER
K872565 · FMF
Hemaedics, Inc.
General Hospital · 183d
Cleared Dec 29, 1987
FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
K872767 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 168d
Cleared Dec 29, 1987
EASI LEAD SYSTEM CABLE ASSEMBLY
K872781 · DRW
Totemite Medical Electronics
Cardiovascular · 168d
Cleared Dec 29, 1987
INSURE PORCELAIN VENEER BONDING SYSTEM
K873356 · EMA
Cosmedent, Inc.
Dental · 131d
Cleared Dec 29, 1987
EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000
K873489 · GCX
J. H. Emerson Co.
General Hospital · 120d
Cleared Dec 29, 1987
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K873522 · FRN
C.R. Bard, Inc.
General Hospital · 119d
Cleared Dec 29, 1987
GAMBRO ADSORBA 150C
K873643 · FLD
Gambro, Inc.
Gastroenterology & Urology · 111d
Cleared Dec 29, 1987
FERRIS ECG ELECTRODE W/HYDROGEL
K873682 · DRX
Ferris Mfg. Corp.
Cardiovascular · 106d
Cleared Dec 29, 1987
RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET
K873729 · FPA
Critikon Company, LLC
General Hospital · 105d
Cleared Dec 29, 1987
CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104
K873859 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 98d
Cleared Dec 29, 1987
CONFIRMATION TESTS
K873907 · HPC
Richmond Products, Inc.
Ophthalmic · 95d
Cleared Dec 29, 1987
BR-2 BIOREST
K873920 · QJQ
Biorest, Inc.
Neurology · 95d
Cleared Dec 29, 1987
INFUMED 300 AMBULATORY INFUSION PUMP
K873961 · FRN
Med Fusion Systems, Inc.
General Hospital · 91d
Cleared Dec 29, 1987
CAREY CAPSULE
K873996 · KNW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Dec 29, 1987
HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)
K874003 · OCZ
Endovations
Gastroenterology & Urology · 89d
Cleared Dec 29, 1987
ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125)
K874004 · OCZ
Endovations
Gastroenterology & Urology · 89d
Cleared Dec 29, 1987
RAT TOOTH GRASPING FORCEP (MODEL 23/20)
K874005 · OCZ
Endovations
Gastroenterology & Urology · 89d
Cleared Dec 29, 1987
GRASPING TRIPOD FORCEP (MODEL 23/25)
K874006 · OCZ
Endovations
Gastroenterology & Urology · 89d