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
5257–5280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2024
TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
K242015 · IZL
DRGEM Corporation
Radiology · 159d
Cleared Dec 16, 2024
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
K242003 · JXG
Aesculap, Inc.
Neurology · 160d
Cleared Dec 16, 2024
AIM (N/A)
K240937 · CCK
Inventeur, LLC
Anesthesiology · 255d
Cleared Dec 16, 2024
TEMBO Embolic System
K240873 · KRD
Instylla, Inc.
Cardiovascular · 262d
Cleared Dec 16, 2024
LUOFUCON® Silver Collagen Dressing
K240809 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 266d
Cleared Dec 16, 2024
MSKai
K240793 · QIH
Mskai
Radiology · 269d
Cleared Dec 16, 2024
ULTIMUS Series Ultrasound Diagnostic System
K240676 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 280d
Cleared Dec 16, 2024
Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric...
K232839 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 459d
Cleared Dec 14, 2024
Sim&Size
K242124 · PZO
Sim&Cure
Neurology · 148d
Cleared Dec 13, 2024
aprevo® anterior lumbar interbody fusion device with interfixation
K243635 · OVD
Carlsmed, Inc.
Orthopedic · 18d
Cleared Dec 13, 2024
Remex Spine Surgery Navigation Instrument
K243560 · OLO
Remex Medical Corp.
Orthopedic · 25d
Cleared Dec 13, 2024
Agilis NxT Steerable Introducer Dual-Reach
K243493 · DYB
Abbott Medical
Cardiovascular · 31d
Cleared Dec 13, 2024
LCD Monitor (MDEC-2523)
K243307 · GCJ
Barco N.V.
General & Plastic Surgery · 53d
Cleared Dec 13, 2024
LOCK-IN Spinal Fixation System
K243281 · NKB
Lock-In USA Corp
Orthopedic · 57d
Cleared Dec 13, 2024
Uro-G HD Cystoscope (1520)
K243196 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 73d
Cleared Dec 13, 2024
Gastro Concepts Air Assist
K242668 · FER
Gastro Concepts, LLC
Gastroenterology & Urology · 99d
Cleared Dec 13, 2024
BTL-785BNF-E
K242532 · NFO
BTL Industries, Inc.
Neurology · 109d
Cleared Dec 13, 2024
Laminar P1 (LDH-HW-001)
K242487 · JAF
Laminar Digital Health, Inc.
Cardiovascular · 114d
Cleared Dec 13, 2024
ARIA Radiation Therapy Management System (18.1)
K242463 · MUJ
Varian Medical Systems, Inc.
Radiology · 116d
Cleared Dec 13, 2024
Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW,...
K241998 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 157d
Cleared Dec 13, 2024
CAIs Sensor (CAIs-001)
K241160 · GXY
Brainu Co., Ltd.
Neurology · 231d
Cleared Dec 13, 2024
ABL90 FLEX PLUS System
K240998 · CHL
Radiometer Medicals Aps
Chemistry · 246d
Cleared Dec 13, 2024
Anterion
K240924 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 253d
Cleared Dec 13, 2024
Vivo 3
K240779 · MNT
Breas Medical AB
Anesthesiology · 267d