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
3145–3168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2025
Monitor B105M
K242562 · MHX
Ge Medical Systems Information...
Cardiovascular · 315d
Cleared Jul 08, 2025
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K251804 · NKB
S.M.A.I.O
Orthopedic · 26d
Cleared Jul 08, 2025
EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
K251776 · JWH
Encore Medical, L.P.
Orthopedic · 28d
Cleared Jul 08, 2025
TumorSight Viz
K251766 · QIH
SimBioSys, Inc.
Radiology · 29d
Cleared Jul 08, 2025
Anovo Surgical System (Model 6Ne)
K251761 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 29d
Cleared Jul 08, 2025
PathLoc Lumbar Interbody Fusion Cage System
K251741 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 32d
Cleared Jul 08, 2025
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
K251447 · FMI
Terumo Europe N.V.
General Hospital · 60d
Cleared Jul 08, 2025
Single-use Ureteral Access Sheath
K250695 · FED
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 123d
Cleared Jul 08, 2025
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use...
K250342 · LZA
Encompass Industries Sdn. Bhd.
General Hospital · 152d
Cleared Jul 08, 2025
DENSITY
K250065 · GEI
Jeisys Medical Incorporated
General & Plastic Surgery · 179d
Cleared Jul 08, 2025
ExcelsiusXR™
K241525 · SBF
Globus Medical, Inc.
Orthopedic · 404d
Cleared Jul 08, 2025
Quantum Micro-Cardioplegia Delivery System
K240908 · DTR
Spectrum Medical , Ltd.
Cardiovascular · 462d
Cleared Jul 07, 2025
CustomSurg OrthoPlanner
K251863 · LLZ
Customsurg AG
Radiology · 20d
Cleared Jul 07, 2025
TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
K251502 · MAX
Life Spine, Inc.
Orthopedic · 53d
Cleared Jul 07, 2025
aprevo® anterior lumbar interbody fusion device
K250827 · MAX
Carlsmed, Inc.
Orthopedic · 111d
Cleared Jul 07, 2025
Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
K250496 · LZA
Zibo Shengkun Chemical Industry Co.,...
General Hospital · 137d
Cleared Jul 07, 2025
TAVIPILOT
K243884 · OWB
Caranx Medical
Radiology · 201d
Cleared Jul 03, 2025
Biograph Vision PET/CT Systems
K251671 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Jul 03, 2025
Single-use Ureteral Access Sheath
K251599 · FED
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 37d
Cleared Jul 03, 2025
syngo.via MI Workflows
K251528 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Jul 03, 2025
MTA vpt
K251390 · KIF
Voco GmbH
Dental · 59d
Cleared Jul 03, 2025
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
K251291 · FGE
Boston Scientific
Gastroenterology & Urology · 69d
Cleared Jul 03, 2025
IdentiTi II Cervical Interbody System
K251080 · ODP
Alphatec Spine, Inc.
Orthopedic · 86d
Cleared Jul 03, 2025
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
K251054 · FZP
Teleflex Medical
General & Plastic Surgery · 90d