FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Cleared only ×
175,230 results
42217–42240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214 · MAV
Boston Scientific Corp
Cardiovascular · 29d
Cleared Nov 09, 2012
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
K112091 · MEH
Lima Corporate S.P.A.
Orthopedic · 477d
Cleared Nov 09, 2012
VOLTERA POWERED SUCTION PUMP
K112853 · OMP
Suzric Enterprise Co., Ltd.
General & Plastic Surgery · 407d
Cleared Nov 09, 2012
ALN OPTIONAL VANA CAVA FILTER
K113124 · DTK
Aln Implants Chirurgicaux
Cardiovascular · 385d
Cleared Nov 09, 2012
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K113314 · LFR
Hmd Biomedical, Inc.
Chemistry · 366d
Cleared Nov 09, 2012
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
K120888 · GWQ
Nihon Kohden Corp.
Neurology · 231d
Cleared Nov 09, 2012
MICRO/MINI N-PK(F) BONE ANCHOR
K121354 · MBI
Anulex Technologies, Inc.
Orthopedic · 189d
Cleared Nov 09, 2012
MICRO/MINI N-PK(H) BONE ANCHOR
K121356 · MBI
Anulex Technologies, Inc.
Orthopedic · 189d
Cleared Nov 09, 2012
CRIT-LINE CLIP (CLIC)
K121599 · KOC
Fresenius Medical Care North America
Gastroenterology & Urology · 161d
Cleared Nov 09, 2012
NEWPORT AURA VENTILATOR
K121891 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 133d
Cleared Nov 09, 2012
REGEN SPRAY APPLICATOR,
K122122 · FMF
Regen Lab SA
General Hospital · 115d
Cleared Nov 09, 2012
AIR-BAND RADIAL COMPRESSION DEVICE
K122405 · DXC
Datascope Corp., Cardiac Assist Division
Cardiovascular · 94d
Cleared Nov 09, 2012
AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700
K122580 · GEI
Encision, Inc.
General & Plastic Surgery · 78d
Cleared Nov 09, 2012
PERSONA NATURAL TIBIA BASEPLATES
K122765 · JWH
Zimmer, Inc.
Orthopedic · 60d
Cleared Nov 08, 2012
CORVIS ST
K113066 · HKX
Oculus Optikgerate GmbH
Ophthalmic · 388d
Cleared Nov 08, 2012
DCS LACRIMAL STENT
K113316 · OKS
Dcs Surgical, Inc.
Ophthalmic · 365d
Cleared Nov 08, 2012
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
K113601 · HRS
Aap Implantate AG
Orthopedic · 339d
Cleared Nov 08, 2012
MTF FASCIA
K120479 · OWY
Musculoskeletal Transplant Foundation
Orthopedic · 266d
Cleared Nov 08, 2012
ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
K120873 · NHA
Zimmer Dental, Inc.
Dental · 231d
Cleared Nov 08, 2012
TERUMO(R) NEEDLE
K121607 · FMI
Terumo (Philippines) Corporation
General Hospital · 160d
Cleared Nov 08, 2012
STINGRAY GUIDEWIRES
K122795 · DQX
Bridgepoint Medical
Cardiovascular · 57d
Cleared Nov 07, 2012
COMEN MULTI-PARAMETER PATIENT MONITOR
K112877 · MWI
Goldway Us, Inc.
Cardiovascular · 404d
Cleared Nov 07, 2012
CLEARLUMEN THROMBECTOMY SYSTEM
K120508 · QEZ
Walk Vascular, LLC
Cardiovascular · 260d
Cleared Nov 07, 2012
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
K121277 · HWC
Z-Medical GmbH & Co. KG
Orthopedic · 194d