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
8977–9000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2023
G4Derm / G4Derm Plus Synthetic Wound Matrix
K222025 · FRO
Gel4med, Inc.
General & Plastic Surgery · 457d
Cleared Oct 10, 2023
ID NOW Influenza A & B 2
K232775 · OCC
Abbott Diagnostics Scarborough, Inc.
Microbiology · 29d
Cleared Oct 10, 2023
Vy Spine™ VyLam™ Laminoplasty System
K232471 · NQW
Vy Spine, LLC
Orthopedic · 55d
Cleared Oct 10, 2023
CarboClear® Pedicle Screw System
K232341 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 67d
Cleared Oct 10, 2023
VEOS Spinal Fixation System
K231658 · NKB
Spineway
Orthopedic · 125d
Cleared Oct 10, 2023
IPD Dental Implant Abutments
K231413 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 147d
Cleared Oct 10, 2023
Zeus Spinal System
K230961 · NKB
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 188d
Cleared Oct 10, 2023
WeSensor
K230916 · MUH
Picopack, Inc.
Radiology · 190d
Cleared Oct 10, 2023
Micromate™ Navi+
K230130 · JAK
Isys Medizintechnik GmbH
Radiology · 266d
Cleared Oct 10, 2023
NeuroTrigger Basic (NTB)
K223027 · IPF
Neurotrigger
Physical Medicine · 376d
Cleared Oct 06, 2023
ScanNav Anatomy Peripheral Nerve Block
K232787 · QRG
Intelligent Ultrasound Limited
Anesthesiology · 25d
Cleared Oct 06, 2023
Swoop® Portable MR Imaging System®
K232760 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Oct 06, 2023
Arthrex FiberTape and TigerTape Cerclage Sutures
K232755 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Oct 06, 2023
2.7 mm GRYPHON™ Flex Knotless PEEK Anchor
K232492 · MBI
Medos International SARL
Orthopedic · 50d
Cleared Oct 06, 2023
ProtekDuo Veno-Venous Cannula Sets
K232480 · PZS
Cardiacassist, Inc.
Cardiovascular · 51d
Cleared Oct 06, 2023
JuggerKnot Soft Anchor OC
K232411 · MBI
Riverpoint Medical, LLC
Orthopedic · 57d
Cleared Oct 06, 2023
Cautery Protective Actuation System (CPAS)
K232407 · GEI
Safer Surgeries Medical Devices, LLC
General & Plastic Surgery · 57d
Cleared Oct 06, 2023
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
K232276 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 67d
Cleared Oct 06, 2023
Ascend VBR System, Ascend NanoTec VBR System
K232173 · MQP
Alphatec Spine, Inc.
Orthopedic · 77d
Cleared Oct 06, 2023
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
K232056 · OHT
Dongguan Lide Electric Appliance Co.,...
General & Plastic Surgery · 87d
Cleared Oct 06, 2023
Vial Adapter
K232055 · LHI
Shanghai Lingfu Technology Co., Ltd.
General Hospital · 87d
Cleared Oct 06, 2023
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with...
K232046 · PIF
Xeridiem Medical Devices, A Spectrum...
Gastroenterology & Urology · 88d
Cleared Oct 06, 2023
Invictus Robotic Navigation Instruments
K232044 · OLO
Alphatec Spine, Inc.
Orthopedic · 88d
Cleared Oct 06, 2023
ProBeam 360° Proton Therapy System v2.0 (Multiroom)
K231863 · LHN
Varian Medical Systems, Inc.
Radiology · 105d