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.

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

Filters: Cleared only ×
175,820 results
143809–143832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1986
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5
K861537 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 77d
Cleared Jul 10, 1986
COTTON FILLED GAUZE SPONGES 2 X 2
K861727 · EFN
Cross Country Paper Products Corp.
Dental · 65d
Cleared Jul 10, 1986
CURITY VENOUS CATHETERIZATION KIT
K861828 · DQY
The Kendal Co.
Cardiovascular · 59d
Cleared Jul 10, 1986
CURITY CENTRAL VENOUS CATHETER
K861829 · DQY
The Kendal Co.
Cardiovascular · 59d
Cleared Jul 10, 1986
515A NEO-TRAK NEONATAL MONITOR
K861861 · KLK
Ge Medical Systems Information...
Anesthesiology · 57d
Cleared Jul 10, 1986
ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER
K861916 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 52d
Cleared Jul 10, 1986
V-MARC 88A COMPUTER
K862089 · KQH
V.Marc, A Div. of Pictorial, Inc.
Hematology · 38d
Cleared Jul 10, 1986
MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD
K862257 · DTB
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD
K862258 · DTB
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD
K862259 · DTB
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR
K862318 · JPK
Fisher Scientific Co., LLC
Hematology · 22d
Cleared Jul 10, 1986
SUCTION T CONNECTOR
K862434
Acutronic Medical Systems AG
Anesthesiology · 14d
Cleared Jul 10, 1986
MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS
K862443 · DTB
Medtronic Vascular
Cardiovascular · 14d
Cleared Jul 10, 1986
RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC
K862468 · IMJ
Rich-Mar Corp.
Physical Medicine · 10d
Cleared Jul 10, 1986
RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC
K862469 · IMJ
Rich-Mar Corp.
Physical Medicine · 10d
Cleared Jul 10, 1986
HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)
K862555 · KIR
Viromed Laboratories, Inc.
Pathology · 7d
Cleared Jul 09, 1986
HUNTLEIGH DOPCORD, D140
K854267 · KNG
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 259d
Cleared Jul 09, 1986
AIR-CUSHION TOCOTONOMETER
K860933 · HFM
International Biomedics, Inc.
Obstetrics & Gynecology · 119d
Cleared Jul 09, 1986
INTERSTIM 100 SYSTEM
K861136 · IPF
Buckman Co., Inc.
Physical Medicine · 105d
Cleared Jul 09, 1986
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
K861710 · DXK
Johnson & Johnson Professionals, Inc.
Cardiovascular · 65d
Cleared Jul 09, 1986
RESTOR (COMET)*DENTAL RESTORATIVE
K861833 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 57d
Cleared Jul 09, 1986
FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
K862072 · HGL
International Biomedics, Inc.
Obstetrics & Gynecology · 40d
Cleared Jul 09, 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163 · FRO
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 33d
Cleared Jul 09, 1986
# 10099/10225/10235/10275/10525/10625/10715/10125
K862193 · CAN
U.O. Equipment Co.
Anesthesiology · 30d