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
157729–157752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1983
SCISSORS
K823651
Fred Sammons, Inc.
Physical Medicine · 59d
Cleared Feb 03, 1983
PRIMARY SOLUTION SALVENT BASED COAT- MET
K823652
Fred Sammons, Inc.
Physical Medicine · 59d
Cleared Feb 03, 1983
THINNING SOLUTION SALVENT BASED COAT-MAT
K823653
Fred Sammons, Inc.
Physical Medicine · 59d
Cleared Feb 03, 1983
BOOK ON MGMT. OF THE BURN PATIENT
K823655
Fred Sammons, Inc.
Physical Medicine · 59d
Cleared Feb 02, 1983
SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
K823389 · JFP
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 02, 1983
AUTO-TENS MODEL IV -DUAL CHANNEL FULL
K823464 · GZJ
Cbc Corp.
Neurology · 75d
Cleared Feb 02, 1983
AUTO-TENS MODEL II SINGLE CHANNEL
K823465 · GZJ
Cbc Corp.
Neurology · 75d
Cleared Feb 02, 1983
PROGRAM. TREADMILL CONTROLLER #645
K830146 · IOL
Quinton, Inc.
Physical Medicine · 16d
Cleared Feb 02, 1983
COLLES FRACTURE FRAME
K830154 · JEC
Richard'S Medical Equip., Inc.
Orthopedic · 15d
Cleared Feb 01, 1983
MODEL F1 HEARING AID
K823067 · ESD
Katz Hearing Aid Center
Ear, Nose, Throat · 105d
Cleared Feb 01, 1983
MEDOX OXYGEN SYSTEM
K823172 · CAW
Mepecc Intl.
Anesthesiology · 92d
Cleared Feb 01, 1983
GLYCO HB QUIK COLUMN PROCEDURE
K823869 · LCP
Helena Laboratories
Hematology · 40d
Cleared Feb 01, 1983
BETA THALQUIK COLUMN #5341
K823870 · JPD
Helena Laboratories
Hematology · 40d
Cleared Feb 01, 1983
HEMATOLOGY QUALITY CONTROL MIXTURE
K823930 · GJP
Fisher Scientific Co., LLC
Hematology · 34d
Cleared Feb 01, 1983
PHONIC EAR
K830098 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 21d
Cleared Feb 01, 1983
MAC LEE UI URINE COLLECTION BAG
K830192 · KNX
Mac Lee Medical Products
Gastroenterology & Urology · 12d
Cleared Jan 28, 1983
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268 · GWN
Kelleher Corp.
Neurology · 183d
Cleared Jan 28, 1983
EMERGENCY TRACHEOSTOMY INSTRUMENT SET
K822618 · LJW
Kelleher Corp.
Ear, Nose, Throat · 148d
Cleared Jan 28, 1983
URITEST 9, INLAB REAGENT STRIPS URINALY
K822709 · JMA
Laprol Scientific, Inc.
Chemistry · 143d
Cleared Jan 28, 1983
NEPHROSTOMY CATHETER
K823382 · LJE
Umi, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 28, 1983
SURGICAL GAUZE
K823455
Worldwide Surgical Gauze
General & Plastic Surgery · 71d
Cleared Jan 28, 1983
INTRA-ARTICULAR C02 INSUFFLATOR
K823499 · HRX
Surgical Instrument Repair Service Co.
Orthopedic · 65d
Cleared Jan 28, 1983
CYCLIC ADENOSINE MONOPHOSHATE BY RADIO
K823504 · CHO
Immuno Nuclear Corp.
Chemistry · 65d
Cleared Jan 28, 1983
DILUENT, ZEROING SOLUTION & CO-OX/ISE
K823535 · JKT
Shaban Mfg. Co.
Toxicology · 59d