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
5857–5880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2024
INNOVANCE Anti-Xa (OPPU05)
K240315 · QLU
Siemens Healthcare Diagnostics...
Hematology · 251d
Cleared Oct 10, 2024
BTI Interna 3.0 Dental Implant System UnicCa®
K240262 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 253d
Cleared Oct 10, 2024
KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System
K233947 · MAX
Ctl Medical Corporation
Orthopedic · 301d
Cleared Oct 10, 2024
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
K230325 · NKB
Greens Surgicals Pvt. , Ltd.
Orthopedic · 612d
Cleared Oct 09, 2024
OsteoCentric Technologies Cannulated Fasteners and Nuts
K242691 · HWC
OsteoCentric Technologies
Orthopedic · 30d
Cleared Oct 09, 2024
TRAP EASY
K242029 · KNW
H.S Hospital Service S.P.A
General & Plastic Surgery · 90d
Cleared Oct 09, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242021 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 09, 2024
Limbus Contour
K241837 · QKB
Limbus Ai, Inc.
Radiology · 106d
Cleared Oct 09, 2024
TruAbutment DS
K241485 · NHA
Truabutment, Inc.
Dental · 138d
Cleared Oct 09, 2024
aprevo® anterior lumbar interbody fusion device with interfixation
K241477 · OVD
Carlsmed, Inc.
Orthopedic · 138d
Cleared Oct 09, 2024
SER Pen Carain MicroSystem (MP1209SP)
K241355 · QAI
Su-Ko Technologies, LLC
General & Plastic Surgery · 148d
Cleared Oct 09, 2024
eMVFit (MVF-10M)
K240991 · PBX
Weero Co., Ltd.
General & Plastic Surgery · 181d
Cleared Oct 09, 2024
Clavicle and Scapula System
K240181 · HRS
Auxein Medical Pvt., Ltd.
Orthopedic · 260d
Cleared Oct 09, 2024
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K240095 · LRX
Shanghai Care US Medical Product Co.,...
Ophthalmic · 271d
Cleared Oct 09, 2024
MEDIYAG
K231948 · GEX
Medicreations, LLC
General & Plastic Surgery · 467d
Cleared Oct 08, 2024
ProLift Wedge Expandable Spacer System
K242826 · MAX
Life Spine, Inc.
Orthopedic · 20d
Cleared Oct 08, 2024
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
K242391 · LPL
Lucens Technology Co., Ltd.
Ophthalmic · 57d
Cleared Oct 08, 2024
Gemini Medical Cage System
K242267 · MAX
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 68d
Cleared Oct 08, 2024
Jet Flow Bulk
K242014 · EBF
Meta Biomed Co., Ltd.
Dental · 90d
Cleared Oct 08, 2024
Nerivio
K241756 · QGT
Theranica Bio-Electronics, Ltd.
Neurology · 112d
Cleared Oct 08, 2024
Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
K241446 · IRP
Sichuan Qianii-Beoka Medical...
Physical Medicine · 139d
Cleared Oct 08, 2024
Sejoy Blood Glucose Monitoring System
K240640 · NBW
Sejoy Biomedical Co., Ltd.
Chemistry · 216d
Cleared Oct 08, 2024
Power Wheelchair (JJW-6001)
K240563 · ITI
ZheJiang J&J Mobility Co., Ltd.
Physical Medicine · 222d
Cleared Oct 08, 2024
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
K240379 · MOL
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 244d