FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
14137–14160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2022
CATALYS Precision Laser system
K220516 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 83d
Cleared May 17, 2022
Imperative Care Radial 088 Access System
K220807 · QJP
Imperative Care, Inc.
Neurology · 60d
Cleared May 17, 2022
MULTIX Impact E
K220919 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared May 17, 2022
syngo.CT CaScoring
K221219 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared May 17, 2022
BriefCase
K221240 · QAS
Aidoc Medical , Ltd.
Radiology · 18d
Cleared May 16, 2022
Clicky Cross
K210516 · FMG
Yomura Technologies, Inc.
General Hospital · 447d
Cleared May 16, 2022
SONON Ultrasound Imaging System, Model: SONON300C
K211665 · IYN
Healcerion Co., Ltd.
Radiology · 349d
Cleared May 16, 2022
Caas Qardia
K212376 · LLZ
Pie Medical Imaging BV
Radiology · 290d
Cleared May 16, 2022
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
K213583 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 185d
Cleared May 16, 2022
AAMI3 Isolation Gown
K213832 · FYC
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 158d
Cleared May 16, 2022
STERRAD NX with ALLClear Technology
K220404 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 91d
Cleared May 16, 2022
IPL HAIR REMOVAL HANDSET, Model: IPL-666
K220669 · OHT
Shenzhen Junbobeauty Technology Co.,...
General & Plastic Surgery · 70d
Cleared May 14, 2022
Disposable Medical Nitrile Examination Gloves -Tested for Use with...
K220491 · LZC
Hainan Asther Medical Equipment Co.,...
General Hospital · 81d
Cleared May 14, 2022
Introcan Safety IV Catheter
K220626 · FOZ
B.Braun Medical, Inc.
General Hospital · 71d
Cleared May 13, 2022
HDF Assist Mudule, HDF Infusion Set and Substitution Filter
K210575 · KDI
Nephros
Gastroenterology & Urology · 441d
Cleared May 13, 2022
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull...
K210615 · GZT
Thompson Surgical Instruments, Inc.
Neurology · 438d
Cleared May 13, 2022
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
K212475 · EJK
Prevest Denpro Limited
Dental · 280d
Cleared May 13, 2022
Spectral CT on Rails
K212875 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 246d
Cleared May 13, 2022
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
K213119 · LPL
Innova Vision, Inc.
Ophthalmic · 228d
Cleared May 13, 2022
INTDose
K213137 · IYE
Carina Medical, LLC
Radiology · 228d
Cleared May 13, 2022
Provena(TM) Midline Catheter
K213203 · PND
C.R. Bard, Inc.
General Hospital · 226d
Cleared May 13, 2022
Sterile Safety Hypodermic Needles for Single Use
K213535 · FMI
Zhejiang Kangkang Medical-Devices...
General Hospital · 189d
Cleared May 13, 2022
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
K213785 · KWS
Limacorporate
Orthopedic · 158d
Cleared May 13, 2022
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
K220115 · OVD
MiRus, LLC
Orthopedic · 119d