FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75337–75360 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 17, 2002
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · KHE
Alfa Scientific Designs, Inc.
Hematology · 45d
Cleared Jun 17, 2002
CARDIOSPECT D90/CARDIO CAM
K021823 · KPS
Nuclear Cardiology Systems, Inc.
Radiology · 13d
Cleared Jun 14, 2002
AIRCAST, MODEL #3011
K013297 · JOW
Millenium Reprocessing Services, Inc.
Cardiovascular · 254d
Cleared Jun 14, 2002
ECHO-SCREEN T, TA, TD, TDA, TC
K013977 · GWJ
Fischer-Zoth Audiologic Systems, Inc.
Neurology · 193d
Cleared Jun 14, 2002
ENDOMAP
K014113 · HAW
Siemens Medical Solutions USA, Inc.
Neurology · 182d
Cleared Jun 14, 2002
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL...
K020857 · DRN
Vasomedical, Inc.
Cardiovascular · 88d
Cleared Jun 14, 2002
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL,...
K020896 · DTE
Osypka Medical, Inc.
Cardiovascular · 87d
Cleared Jun 14, 2002
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
K020907 · IKT
Medicotest A/S
Neurology · 86d