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
74809–74832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021627 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Jun 20, 2002
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K021695 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared Jun 20, 2002
EQUALIZER BALLOON CATHETER
K021721 · DQY
Boston Scientific Corp
Cardiovascular · 27d
Cleared Jun 19, 2002
SLEEP PAT 200 DEVICE
K010156 · MNR
Itamar Medical (C.M.) 1997 , Ltd.
Anesthesiology · 519d
Cleared Jun 19, 2002
OXYGEN TREATMENT HOOD
K011592 · CBF
Amron International Diving Supply, Inc.
Anesthesiology · 391d
Cleared Jun 19, 2002
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR
K013896 · MKJ
Defibtech, LLC
Cardiovascular · 208d
Cleared Jun 19, 2002
DEVILBISS PD1000
K020329 · NFB
Sunrise Medical Hhg, Inc.
Anesthesiology · 139d
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