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
5185–5208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2024
BioSphere Putty
K241167 · MQV
Synergy Biomedical
Orthopedic · 238d
Cleared Dec 20, 2024
Alpha Dent Implants Dental Implants System
K240435 · DZE
Alpha Dent Implants GmbH
Dental · 310d
Cleared Dec 20, 2024
SmartClip Secure Soft Tissue Marker
K233639 · NEU
Elucent Medical, Inc.
General & Plastic Surgery · 403d
Cleared Dec 19, 2024
BD Vaginal Panel
K243725 · PQA
Becton, Dickinson and Company
Microbiology · 16d
Cleared Dec 19, 2024
Saige-Density (2.5.0)
K243705 · QIH
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 19, 2024
Saige-Dx (3.1.0)
K243688 · QDQ
DeepHealth, Inc.
Radiology · 20d
Cleared Dec 19, 2024
Monoject™ Enteral Syringe with ENFit Connector (401SE)
K243652 · PNR
Cardinalhealth
Gastroenterology & Urology · 23d
Cleared Dec 19, 2024
OviTex PRS (Long-Term Resorbable)
K243595 · FTM
TELA Bio, Inc.
General & Plastic Surgery · 29d
Cleared Dec 19, 2024
Electric Wheelchair (HC820N)
K243440 · ITI
Yongkang Hengyi Vehicle Co., Ltd.
Physical Medicine · 43d
Cleared Dec 19, 2024
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
K243430 · NFO
Shenzhen Aozemei Technology Co., Ltd.
Neurology · 44d
Cleared Dec 19, 2024
Nutrifit
K243361 · FPD
Vygon USA
Gastroenterology & Urology · 51d
Cleared Dec 19, 2024
Yushan X-Ray Flat Panel Detector
K243171 · MQB
Innocare Optoelectronics Corp.
Radiology · 80d
Cleared Dec 19, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K243169 · JWY
Thermo Fisher Scientific
Microbiology · 80d
Cleared Dec 19, 2024
Quickdent Dental Implant System
K243094 · DZE
Quickdent Devices Private , Ltd.
Dental · 80d
Cleared Dec 19, 2024
Bovine Dermis Collagen Dermal Matrix
K243071 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 83d
Cleared Dec 19, 2024
Integrity V500 (Integrity, Integrity with VEMP)
K242954 · GWJ
Vivosonic, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 19, 2024
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD,...
K242908 · FTC
Shanghai Sigma High-Tech Co., Ltd.
General & Plastic Surgery · 86d
Cleared Dec 19, 2024
Cristaline Aligners Z FLX
K242892 · NXC
Cristaline Aligners GmbH
Dental · 87d
Cleared Dec 19, 2024
IPD Dental Implant Abutments
K242819 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 92d
Cleared Dec 19, 2024
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72,...
K242700 · OHS
Shenzhen Nuon Medical Equipment Co.,...
General & Plastic Surgery · 101d
Cleared Dec 19, 2024
IQ-UIP
K242467 · QWO
Imbio, Inc.
Radiology · 121d
Cleared Dec 19, 2024
Medline Microdissection Needle (4cm) (140936 (ESE104A))
K242370 · GEI
Medline Industries, LP
General & Plastic Surgery · 132d
Cleared Dec 19, 2024
OrthoNext Platform System
K242270 · QIH
Orthofix Srl
Radiology · 140d
Cleared Dec 19, 2024
LibAirty Airway Clearance System
K242063 · BYI
Synchrony Medical , Ltd.
Anesthesiology · 157d