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
13081–13104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2022
KLS Martin Neuro Rongeurs
K210741 · HAE
KLS-Martin L.P.
Neurology · 448d
Cleared Jun 03, 2022
eCareManager 4.5
K211046 · MSX
Visicu, Inc.
Cardiovascular · 421d
Cleared Jun 03, 2022
BiMobile Instruments (for BiMobile Dual Mobility System)
K211567 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 378d
Cleared Jun 03, 2022
Multifrax Laser System
K213332 · ONG
Paradigm Medical Corporation
General & Plastic Surgery · 240d
Cleared Jun 03, 2022
Gastric Alimetry System
K213924 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 170d
Cleared Jun 03, 2022
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
K213931 · LON
bioMerieux, Inc.
Microbiology · 169d
Cleared Jun 03, 2022
Atrial Fibrillation History Feature
K213971 · QDB
Apple, Inc.
Cardiovascular · 165d
Cleared Jun 03, 2022
TrueBeam, TrueBeam STx, Edge, VitalBeam
K213977 · IYE
Varian Medical Systems, Inc.
Radiology · 165d
Cleared Jun 03, 2022
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
K213988 · LZU
Oasis Medical, Inc.
Ophthalmic · 165d
Cleared Jun 03, 2022
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle,...
K214063 · KNW
Guangzhou Shengwei Medical Devices...
General & Plastic Surgery · 158d
Cleared Jun 03, 2022
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089 · ODG
Fujifilm Corporation
Radiology · 157d
Cleared Jun 03, 2022
3D Anatomic Models
K220205 · LLZ
Ricoh USA, Inc.
Radiology · 129d
Cleared Jun 03, 2022
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test...
K220321 · QEP
Hologic, Inc.
Microbiology · 120d
Cleared Jun 03, 2022
MICROLET NEXT lancing device, MICROLET Lancet
K220633 · QRL
Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery · 91d
Cleared Jun 03, 2022
Knee 3
K220652 · OLO
Brainlab AG
Orthopedic · 88d
Cleared Jun 03, 2022
Surgical Gown, Blue, Sterile
K220665 · FYA
Excellent Medical Technology Group...
General Hospital · 88d
Cleared Jun 03, 2022
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy...
K220672 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 88d
Cleared Jun 03, 2022
CIRCUL8 Connect DVT Prevention Device
K220761 · JOW
Ortho8, Inc.
Cardiovascular · 80d
Cleared Jun 03, 2022
21HQ613D
K221061 · PGY
Lg Electronics.Inc
Radiology · 53d
Cleared Jun 03, 2022
BriefCase
K221314 · QAS
Aidoc Medical , Ltd.
Radiology · 29d
Cleared Jun 02, 2022
Hemosure Accu-Reader A100
K200754 · OOX
W.H.P.M., Inc.
Hematology · 801d
Cleared Jun 02, 2022
Q Patch
K210758 · MWJ
Medicalgorithmics S.A.
Cardiovascular · 444d
Cleared Jun 02, 2022
Minjie Catheter System
K212288 · QJP
Kai Medtech, LLC
Neurology · 316d
Cleared Jun 02, 2022
Endoscopic Injection Needle
K213239 · FBK
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 245d