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
12169–12192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2022
BD MAX Enteric Viral Panel
K220607 · PCH
Becton, Dickinson and Company
Microbiology · 203d
Cleared Sep 21, 2022
SomnoMetry
K221179 · OLZ
Neumetry Medical, Inc.
Neurology · 149d
Cleared Sep 21, 2022
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608,...
K221214 · ONF
Shenzhen Ionka Medical Technology...
General & Plastic Surgery · 147d
Cleared Sep 21, 2022
MedtFine Blood Lancet
K221383 · QRK
Shanghai Carelife International...
General & Plastic Surgery · 131d
Cleared Sep 21, 2022
SpeediCath Flex Set
K222059 · EZD
Coloplast
Gastroenterology & Urology · 70d
Cleared Sep 21, 2022
ArcSP Suprapubic Sling System
K222293 · OTN
Urocure, LLC
Gastroenterology & Urology · 51d
Cleared Sep 21, 2022
MCB UNIT Model: V10GMCBUS
K222542 · KNS
Lamidey Noury Medical
Gastroenterology & Urology · 30d
Cleared Sep 20, 2022
Aorta-CAD
K213353 · MYN
Imagen Technologies, Inc.
Radiology · 347d
Cleared Sep 20, 2022
LUOFUCON Collagen Wound Dressing
K213598 · KGN
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 309d
Cleared Sep 20, 2022
Millipede 088 Access Catheter
K214048 · QJP
Perfuze, Ltd.
Neurology · 267d
Cleared Sep 20, 2022
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
K214056 · LZA
Mezorrison Medical Technology...
General Hospital · 267d
Cleared Sep 20, 2022
Tandry Compression Screw System
K220359 · HWC
Microware Precision Co., Ltd.
Orthopedic · 224d
Cleared Sep 20, 2022
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
K221227 · FLE
Tuttnauer , Ltd.
General Hospital · 145d
Cleared Sep 20, 2022
Disposable Surgical Gown UM-148
K221717 · FYA
Unimax Medical Products Co., Ltd.
General Hospital · 99d
Cleared Sep 20, 2022
DePuy Synthes 3.5mm Intrapelvic Acetabular System
K221809 · HRS
DePuy Synthes
Orthopedic · 90d
Cleared Sep 20, 2022
JO CUMPLAY Personal Lubricant
K221908 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 82d
Cleared Sep 20, 2022
Surgical Face Mask (Non-sterile)
K221976 · FXX
Xiantao Junhui Plastic Products Co.,...
General Hospital · 77d
Cleared Sep 20, 2022
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
K222642 · LZA
Inner Mongolia Cureguard Medical...
General Hospital · 19d
Cleared Sep 19, 2022
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
K213013 · QNQ
Jeil Tech Co., Ltd.
General Hospital · 364d
Cleared Sep 19, 2022
Pro M Class
K213897 · EKX
Saeyang Microtech Co., Ltd.
Dental · 279d
Cleared Sep 19, 2022
LANDMARK REBOA Catheter
K214060 · MJN
Zien Medical Technologies, Inc.
Cardiovascular · 266d
Cleared Sep 19, 2022
Promisemed X-Safety Pen Needle
K220129 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 244d
Cleared Sep 19, 2022
Arthrex Compression FT Pins
K220839 · HWC
Arthrex, Inc.
Orthopedic · 180d
Cleared Sep 19, 2022
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K221638 · EOB
Olympus Medical Systems Corp.
Ear, Nose, Throat · 105d