Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
68785–68808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2004
RAICHEM BUN RATE REAGENT (LIQUID)
K041051 · CDQ
Hemagen Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 30, 2004
RAICHEM GLUCOSE UV (LIQUID)
K041052 · CFR
Hemagen Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 30, 2004
IMASK TM
K041309 · BZD
Vital Signs, Inc.
Anesthesiology · 44d
Cleared Jun 30, 2004
CONTACT DETACH
K041545 · FPA
Unomedical A/S
General Hospital · 21d
Cleared Jun 30, 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · FRN
Abbott Laboratories
General Hospital · 21d
Cleared Jun 30, 2004
CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
K041569 · GEX
Curelight, Ltd.
General & Plastic Surgery · 20d
Cleared Jun 30, 2004
PRECISION RXI ANALOG X-RAY SYSTEM
K041605 · OWB
General Medical Merate S.P.A
Radiology · 15d
Cleared Jun 30, 2004
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K041686 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 8d
Cleared Jun 29, 2004
PRELUDE
K040952 · KLE
Danville Materials, Inc.
Dental · 78d
Cleared Jun 29, 2004
NC SP02 ADAPTER CABLE
K041204 · DQA
Masimo Corp.
Anesthesiology · 53d
Cleared Jun 29, 2004
G-BOND
K041471 · KLE
GC America, Inc.
Dental · 27d
Cleared Jun 29, 2004
IMAGERAYI
K041580 · MUH
Henry Schein, Inc.
Radiology · 15d
Cleared Jun 28, 2004
BIPRO MODEL SDS-CB200
K033118 · FIN
Medical Solutions International
Gastroenterology & Urology · 272d
Cleared Jun 28, 2004
SCD EXPRESS PORTABLE COMPRESSION SYSTEM
K040511 · JOW
Tyco Healthcare/Kendall
Cardiovascular · 122d
Cleared Jun 28, 2004
CELLSEARCH EPITHELIAL CELL CONTROL KIT
K040898 · NRS
Veridex, LLC
Hematology · 83d
Cleared Jun 28, 2004
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
K041026 · DRX
Ambu, Inc.
Cardiovascular · 68d
Cleared Jun 28, 2004
REMOTENURSE PATIENT MONITORING SYSTEM
K041308 · DXH
Webvmc, LLC
Cardiovascular · 42d
Cleared Jun 28, 2004
LIQUICHEK HEMATOLOGY CONTROL (A)
K041457 · JPK
Bio-Rad
Hematology · 27d
Cleared Jun 25, 2004
ELASTIC SKIN LIQUID BANDAGE
K032948 · KMF
Medpak, LLC
General & Plastic Surgery · 277d
Cleared Jun 25, 2004
INSTEAD INTIMATE LUBRICANT
K033776 · NUC
Instead, Inc.
Obstetrics & Gynecology · 205d
Cleared Jun 25, 2004
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
K040241 · DCK
Genzyme Corp.
Chemistry · 143d
Cleared Jun 25, 2004
TRIAGE PROFILER S.O.B. PANEL
K040437 · DAP
Biosite Incorporated
Chemistry · 127d
Cleared Jun 25, 2004
MEDIA CULTURE SYSTEM
K040530 · MQL
Intl., Inc.
Obstetrics & Gynecology · 116d
Cleared Jun 25, 2004
ONEDOSE PATIENT DOSIMETRY SYSTEM
K040687 · IYE
Sicel Technologies, Inc.
Radiology · 101d