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
75937–75960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 2002
WORKBENCH BY
K020560 · MQG
Intl., Inc.
Obstetrics & Gynecology · 119d
Cleared Jun 19, 2002
PALOMAR LUXG HANDPIECE
K020941 · GEX
Palomar
General & Plastic Surgery · 89d
Cleared Jun 19, 2002
GLO-SPEC I, II AND III
K020959 · HIB
Sol Weiss MD, Inc.
Obstetrics & Gynecology · 86d
Cleared Jun 19, 2002
LEESPEC DISPOSABLE VAGINAL SPECULUM
K021017 · HIB
Itl Corporation Pty, Ltd.
Obstetrics & Gynecology · 82d
Cleared Jun 19, 2002
OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR
K021089 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 76d
Cleared Jun 19, 2002
ELEMENTS DIAGNOSTIC UNIT
K021298 · EAT
Sybron Endo/Analytic
Dental · 56d
Cleared Jun 19, 2002
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
K021567 · CAZ
Arrow Intl., Inc.
Anesthesiology · 37d
Cleared Jun 19, 2002
HANSATOME EXCELLUS MICROKERATOME
K021640 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 30d
Cleared Jun 19, 2002
UNIDRIVE II PLUS DISPOSABLE TUBING SET
K021811 · ERL
Mtp Medical Technical Promotion GmbH
Ear, Nose, Throat · 16d
Cleared Jun 19, 2002
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
K021861 · BZD
Respironics, Inc.
Anesthesiology · 13d
Cleared Jun 19, 2002
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC...
K021886 · FDS
Olympus Optical Co., Ltd.
Radiology · 12d
Cleared Jun 18, 2002
VIVAWAVE MICROWAVE SYSTEM
K011676 · NEY
Vivant Medical, Inc.
General & Plastic Surgery · 384d
Cleared Jun 18, 2002
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
K020335 · OMC
Olympic Medical Corp.
Neurology · 137d
Cleared Jun 18, 2002
OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM
K021009 · KWP
Spinal Concepts, Inc.
Orthopedic · 82d
Cleared Jun 18, 2002
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
K021019 · GAT
Genzyme Corp.
General & Plastic Surgery · 81d
Cleared Jun 18, 2002
MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
K021066 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 77d
Cleared Jun 18, 2002
300 PV COMPLETE ELECTROTHERAPY SYSTEM
K021100 · IPF
Empi
Physical Medicine · 75d
Cleared Jun 18, 2002
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K021449 · DLJ
Lin-Zhi International, Inc.
Toxicology · 43d
Cleared Jun 18, 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · ITI
Invacare Corp.
Physical Medicine · 27d
Cleared Jun 17, 2002
NAKAO SNARE II AND NAKAO SNARE III
K020891 · FDI
Granit Medical Innovations
Gastroenterology & Urology · 90d
Cleared Jun 17, 2002
AMX-4 PLUS MOBILE X-RAY SYSTEM
K021016 · IZL
GE Medical Systems
Radiology · 80d
Cleared Jun 17, 2002
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070...
K021081 · DFZ
The Binding Site, Ltd.
Immunology · 75d
Cleared Jun 17, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
K021181 · JWY
Dade Microscan, Inc.
Microbiology · 63d
Cleared Jun 17, 2002
BLOOD-PRESSURE METER
K021252 · DXN
Idt Technology Limited
Cardiovascular · 59d