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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
159985–160008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1982
VENTED NITROGLYCERIN I.V. SET
K821515 · FPA
Abbott Laboratories
General Hospital · 20d
Cleared Jun 09, 1982
STABILOR NF
K821521 · EJT
J. Aderer, Inc.
Dental · 19d
Cleared Jun 09, 1982
SYRINGE, PISTON
K821528 · FMF
Medcare Disp Products, Inc.
General Hospital · 19d
Cleared Jun 09, 1982
DISPOSABLE HYPODERMIC NEEDLES
K821529 · FMI
Medcare Disp Products, Inc.
General Hospital · 19d
Cleared Jun 09, 1982
MONITORING DEVICE ENURESIS ALARM & ACC.
K821546 · KPN
Wetbell, Inc.
Gastroenterology & Urology · 15d
Cleared Jun 09, 1982
EOSIN Y SOLUTION ALCHOLIC
K821573 · HYB
Sigma Chemical Co.
Pathology · 13d
Cleared Jun 09, 1982
MODEL 580 DIGITAL RADIOGRAPHY SYSTEM
K827501
Technicare Corp.
Radiology · 30d
Cleared Jun 09, 1982
MODEL DPS-4050 DIGITAL RADIOGRAPHY SYSTEM
K827502
Adac Laboratories
Radiology · 36d
Cleared Jun 09, 1982
SIZE SENSING CASSETTE TRAY
K827504
Midwest X-Ray Equipment Co.
Radiology · 36d
Cleared Jun 07, 1982
REIGNING DENTURE
K821217 · EBI
Oki Shiks USA , Ltd.
Dental · 41d
Cleared Jun 07, 1982
DENTAL IMPRESSION MATERIAL
K821221 · ELW
Crown Delta Corp.
Dental · 41d
Cleared Jun 07, 1982
DENTAL AMALGAM ALLOY
K821226 · EJJ
Dental Alloyers Intl., Inc.
Dental · 41d
Cleared Jun 07, 1982
HEAD-UP SUPINE SAFETY SUPPORT CUSHION
K821306 · EPW
Med-Life, Inc.
General & Plastic Surgery · 34d
Cleared Jun 07, 1982
OTICON
K821325 · ESD
Oticon Corp.
Ear, Nose, Throat · 34d
Cleared Jun 07, 1982
GAS STERILIZATION POUCHES
K821330 · FRG
Medical Industries Packaging, Inc.
General Hospital · 34d
Cleared Jun 07, 1982
MEDI-SEAL STERILIZATION POUCHES & TUB
K821331 · FRG
Medical Industries Packaging, Inc.
General Hospital · 34d
Cleared Jun 07, 1982
CUSTOM, IN-THE-EAR HEARING AID
K821390 · ESD
Ear-Tronics, Inc.
Ear, Nose, Throat · 27d
Cleared Jun 04, 1982
E.G. BRIDGE GOLD
K821613 · EJT
J. Aderer, Inc.
Dental · 2d
Cleared Jun 04, 1982
LITERATURE ON THE SONADENT
K827410
L&R Mfg. Co., Inc.
Radiology · 35d
Cleared Jun 03, 1982
PRE-STERILIZATION OF VITALLIUM ALLOY
K820218
Howmedica Corp.
Orthopedic · 128d
Cleared Jun 03, 1982
SEAMED, #540 - SIEMENS, #146F TELECTRO
K820570 · DTE
Seamed Corp.
Cardiovascular · 93d
Cleared Jun 03, 1982
THERATRONIC STIMULATOR
K820782 · IPF
Theratronics, Inc.
Physical Medicine · 72d
Cleared Jun 03, 1982
KEY DRILL
K821127 · GFG
Key Medical, Inc.
General & Plastic Surgery · 44d
Cleared Jun 03, 1982
MAYO-HEGAR NEEDLE HOLDER
K821289 · GDF
Conphar, Inc.
General & Plastic Surgery · 30d