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
5569–5592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2024
QUEX ED
K232779 · OMC
Qx World, Ltd.
Neurology · 396d
Cleared Oct 11, 2024
UriSponge™
K232565 · JSM
Copan Italia Spa
Microbiology · 414d
Cleared Oct 10, 2024
uDR 380i Pro
K242515 · IZL
Shanghai United Imaging Healthcare...
Radiology · 48d
Cleared Oct 10, 2024
Dental porcelain powder
K242400 · EIH
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 58d
Cleared Oct 10, 2024
EyeGility™ Inserter for Preloaded enVista IOLs
K242389 · MSS
Bausch & Lomb, Incorporated
Ophthalmic · 59d
Cleared Oct 10, 2024
Lasya-Trinity
K241951 · GEX
BLUECORE COMPANY Co., Ltd.
General & Plastic Surgery · 99d
Cleared Oct 10, 2024
ProSeal™ In Line Pump Set (423850)
K241735 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 115d
Cleared Oct 10, 2024
Blueprint Patient-Specific Instrumentation
K241491 · PHX
Stryker Corporation (Tornier, S.A.S.)
Orthopedic · 139d
Cleared Oct 10, 2024
EchoMeasure
K241430 · QIH
Icardio.Ai
Radiology · 142d
Cleared Oct 10, 2024
Youlaser PRIME
K241092 · GEX
Quanta System Spa
General & Plastic Surgery · 171d
Cleared Oct 10, 2024
eMVFit (MVF-10M)
K240992 · IPF
Weero Co., Ltd.
Physical Medicine · 182d
Cleared Oct 10, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
K240848 · FAJ
Ambu A/S
Gastroenterology & Urology · 197d
Cleared Oct 10, 2024
AutoChamber
K240786 · QIH
HeartLung Corporation
Radiology · 202d
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