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
107761–107784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1994
AXSYM CK-MB
K935924 · JHW
Abbott Laboratories
Chemistry · 190d
Cleared Jun 21, 1994
POWDER FREE LATEX EXAMINATION GLOVES
K935946 · LYY
Cranberry (M) Sdn. Bhd.
General Hospital · 190d
Cleared Jun 21, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K940364 · LNH
Medical Advances, Inc.
Radiology · 146d
Cleared Jun 21, 1994
ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)
K940505 · HET
Uresil Corp.
Obstetrics & Gynecology · 138d
Cleared Jun 21, 1994
AXSYM VANCOMYCIN
K940595 · LEH
Abbott Laboratories
Toxicology · 131d
Cleared Jun 21, 1994
AXSYM PHENOBARBITAL
K940596 · LGQ
Abbott Laboratories
Toxicology · 131d
Cleared Jun 21, 1994
AXSYM(TM) QUINIDINE
K940682 · LGI
Abbott Laboratories
Chemistry · 131d
Cleared Jun 21, 1994
DR. BOO POWDER-FREE LATEX EXAM GLOVES
K941240 · LYY
Dr. Boo Co., Ltd.
General Hospital · 98d
Cleared Jun 21, 1994
DISPOSABLE SPINAL INTRODUCER SHEATH
K941419 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 90d
Cleared Jun 21, 1994
MRG POWDER FREE LATEX EXAMINATION GLOVES
K941451 · LYY
M.R.G. Industries Sdn. Bhd.
General Hospital · 89d
Cleared Jun 21, 1994
POWDERED LATEX EXAM GLOVES
K941900 · LYY
Tg Medical Sdn. Bhd.
General Hospital · 63d
Cleared Jun 21, 1994
TROCAR SLEEVE, SEALING CAPS, REDUCER, LOOP GUIDE
K942414 · GCJ
Linvatec Corp.
General & Plastic Surgery · 32d
Cleared Jun 20, 1994
620CSR DISPLAY DRIVER
K932894 · DXJ
Vidco, Inc.
Cardiovascular · 371d
Cleared Jun 20, 1994
THE BTE WS30
K933611 · ISD
Baltimore Therapeutic Equipment Co.
Physical Medicine · 336d
Cleared Jun 20, 1994
AFFINITY CVR
K936003 · DTN
Avecor Cardiovascular, Inc.
Cardiovascular · 186d
Cleared Jun 20, 1994
KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION
K936036 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 185d
Cleared Jun 20, 1994
FORTE US
K941561 · IMG
Chattanooga Group, Inc.
Physical Medicine · 80d
Cleared Jun 20, 1994
INTERACOUSTICS DIAGNOSTIC AUDIOMETER
K942006 · EWO
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 56d
Cleared Jun 20, 1994
HAND CONTROLLED SYRINGE
K942329 · DQO
Abbott Laboratories
Cardiovascular · 35d
Cleared Jun 17, 1994
DUAL PORT ENTERAL Y-ADAPTOR
K923168 · KNT
Orion Life Systems, Inc.
Gastroenterology & Urology · 718d
Cleared Jun 17, 1994
STERITUBE
K930072 · KCT
Jordco, Inc.
General Hospital · 527d
Cleared Jun 17, 1994
AMERSE
K931477 · LRJ
Calgon Vestal Div.
General Hospital · 450d
Cleared Jun 17, 1994
AID, PROMISE POWDER FREE LATEX EXAMINATION GLOVES
K931861 · LYY
Taiping Super Holdings Sdn Bhd
General Hospital · 430d
Cleared Jun 17, 1994
CORPAK ENTERAL PUMP
K932847 · FRN
Corpak Co.
General Hospital · 372d