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
93241–93264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1997
BENCHMARK-IV
K971575 · EJT
J.F. Jelenko & Co., Inc.
Dental · 58d
Cleared Jun 04, 1997
STERILE SUREFLEX FILES AND INSTRUMENTS
K971603 · EFA
Dentsply Intl.
Dental · 34d
Cleared Jun 03, 1997
ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER
K964549 · ITX
Aloka Co., Ltd.
Radiology · 202d
Cleared Jun 03, 1997
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
K965204 · KYI
Avanta Orthopaedics, Inc.
Orthopedic · 159d
Cleared Jun 03, 1997
CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR
K970243 · GEX
Cynosure, Inc.
General & Plastic Surgery · 132d
Cleared Jun 03, 1997
SOLO
K970523 · INI
Ranger All Season Corp.
Physical Medicine · 112d
Cleared Jun 03, 1997
TEMPOCEM NE (MULTIPLE)
K970774 · EMA
Foremost Dental Mfg., Inc.
Dental · 91d
Cleared Jun 03, 1997
TEMPO CEM (MULTIPLE)
K970775 · EMA
Foremost Dental Mfg., Inc.
Dental · 91d
Cleared Jun 03, 1997
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S...
K970791 · LTZ
Custom Services Intl., Inc.
Obstetrics & Gynecology · 91d
Cleared Jun 03, 1997
TRU-PULSE CO2 SURGICAL LASER
K970804 · GEX
Tissue Technologies, Inc.
General & Plastic Surgery · 91d
Cleared Jun 03, 1997
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
K970823 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 89d
Cleared Jun 03, 1997
EASY ROD
K970950 · MNH
Acromed Corp.
Orthopedic · 81d
Cleared Jun 03, 1997
OSTEONICS RESTORATION ACETABULAR RING
K970957 · JDJ
Osteonics Corp.
Orthopedic · 78d
Cleared Jun 03, 1997
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
K971036 · GCY
Interpore Intl.
General & Plastic Surgery · 75d
Cleared Jun 03, 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · MID
Hemagen Diagnostics, Inc.
Immunology · 74d
Cleared Jun 03, 1997
OPTIMA PLUS E DENTAL CHAIR
K971063 · KLC
King Dental Corp.
Dental · 71d
Cleared Jun 03, 1997
BIOACCESS MARROW HARVEST SYSTEM
K971114 · GDM
Bioaccess, Inc.
General & Plastic Surgery · 69d
Cleared Jun 03, 1997
AUTO SUTURE* ILM** KIT
K971201 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 63d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS CAL 5 PLUS
K971283 · JIX
Beckman Instruments, Inc.
Immunology · 57d
Cleared Jun 03, 1997
OPALDAM
K971284 · EIG
Ultradent Products, Inc.
Dental · 57d
Cleared Jun 03, 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS...
K971411 · EMX
Bentec Medical, Inc.
Ear, Nose, Throat · 48d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
K971506 · DMT
Beckman Instruments, Inc.
Toxicology · 39d
Cleared Jun 03, 1997
COMPOGLASS F
K971513 · EBF
Ivoclar North America, Inc.
Dental · 36d
Cleared Jun 03, 1997
NOVATIP FAMILY OF LASER HANDPIECE TIPS
K971539 · GEX
Xanova Corp.
General & Plastic Surgery · 36d