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
85873–85896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 1999
EDGE SYSTEMS STERILE TUBING
K990748 · GEX
Edge Systems Corp.
General & Plastic Surgery · 57d
Cleared May 04, 1999
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50...
K990812 · LYY
Ampri Rubberware Industries Sdn Bhd
General Hospital · 54d
Cleared May 04, 1999
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509...
K990829 · MCW
Arrow Intl., Inc.
Cardiovascular · 53d
Cleared May 04, 1999
POWDER FREE LATEX EXAMINATION GLOVES
K990901 · LYY
Apl Products Sdn. Bhd.
General Hospital · 47d
Cleared May 04, 1999
BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES
K990946 · LYZ
Long First (Xiamen) Co., Ltd.
General Hospital · 43d
Cleared May 04, 1999
LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN
K991043 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 36d
Cleared May 04, 1999
SAS HCG-CHECK
K991193 · LCX
Sa Scientific, Inc.
Chemistry · 26d
Cleared May 03, 1999
HEMOCHRON RESPONSE
K983475 · KQG
International Technidyne Corp.
Hematology · 213d
Cleared May 03, 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 194d
Cleared May 03, 1999
BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
K990376 · KNS
Ballard Medical Products
Gastroenterology & Urology · 84d
Cleared May 03, 1999
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
K990704 · DCK
Beckman Coulter, Inc.
Immunology · 60d
Cleared Apr 30, 1999
EXTRACORPOREAL BLOOD CIRCUIT
K982340 · FJK
Haidylena Medical Egypt
Gastroenterology & Urology · 298d
Cleared Apr 30, 1999
SILK SUTURE
K982853 · GAP
Davis & Geck, Inc.
General & Plastic Surgery · 260d
Cleared Apr 30, 1999
SINGLE AXLE TOTAL ELBOW
K983036 · JDC
Biomet, Inc.
Orthopedic · 242d
Cleared Apr 30, 1999
CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM...
K983610 · CAH
Intersurgical, Inc.
General Hospital · 198d
Cleared Apr 30, 1999
SPIROVIT, MODEL SP-250
K984031 · BZG
Schiller AG
Anesthesiology · 169d
Cleared Apr 30, 1999
HP M2376A DEVICE LINK SYSTEM
K984194 · MQS
Hewlett-Packard Co.
Gastroenterology & Urology · 158d
Cleared Apr 30, 1999
OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY
K984375 · KWP
Osteonics Corp.
Orthopedic · 144d
Cleared Apr 30, 1999
AU6
K990360 · IYN
Biosound Esaote, Inc.
Radiology · 84d
Cleared Apr 30, 1999
B2C, ESPACE REVISION CUP SYSTEM
K990523 · LPH
Turnkey Intergration USA, Inc.
Orthopedic · 70d
Cleared Apr 30, 1999
ORTHOPHOS 3/3 CEPH/3 DS
K990528 · MUH
Sirona Dental Systems GmbH
Radiology · 70d
Cleared Apr 30, 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM,...
K990631 · FGE
Cordis Corp.
Gastroenterology & Urology · 63d
Cleared Apr 30, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
K991032 · FGE
Guidant Corp.
Gastroenterology & Urology · 32d
Cleared Apr 30, 1999
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE...
K991223 · GAL
Aesculap, Inc.
General & Plastic Surgery · 18d