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
127441–127464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1990
PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR
K896506 · FGE
Porges Corp.
Gastroenterology & Urology · 72d
Cleared Jan 26, 1990
SFA MODULE
K896528 · DXG
Life Sciences Manufacturing, Inc.
Cardiovascular · 71d
Cleared Jan 26, 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
K896809 · DXY
Medtronic Vascular
Cardiovascular · 53d
Cleared Jan 26, 1990
VENTLAB ANESTHESIA CIRCUIT AC 6000
K896897 · CAI
Ventlab Corp.
Anesthesiology · 49d
Cleared Jan 26, 1990
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
K896926 · KTN
Quidel Corp.
Immunology · 46d
Cleared Jan 26, 1990
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K896957 · LYY
Honyee Enterprise Co.
General Hospital · 43d
Cleared Jan 26, 1990
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
K900164 · BYE
Puritan Bennett Corp.
Anesthesiology · 14d
Cleared Jan 26, 1990
MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE
K900169 · LDD
Laerdal Mfg. Corp.
Cardiovascular · 14d
Cleared Jan 25, 1990
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
K896474 · KHE
Labsystems, Inc.
Hematology · 73d
Cleared Jan 25, 1990
LATEX NON-POWDERED EXAMINATION GLOVES
K896872 · LYY
Thaisan Industries Co., Ltd.
General Hospital · 48d
Cleared Jan 25, 1990
RAICHEM TM HEMOGLOBIN CALIBRATOR
K896921 · KRZ
Reagents Applications, Inc.
Hematology · 45d
Cleared Jan 25, 1990
RAICHEM TM HEMOGLOBIN REAGENT
K896922 · GKK
Reagents Applications, Inc.
Hematology · 45d
Cleared Jan 25, 1990
CLEAN HAND-VCL GLOVE DISPENSER
K897048 · LYY
Safety Today, Inc.
General Hospital · 38d
Cleared Jan 25, 1990
ROCKET REFERENCE PLASMA, CAT NO. 5188
K900019 · GGN
Helena Laboratories
Hematology · 23d
Cleared Jan 25, 1990
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
K900049 · GFO
Medical Diagnostic Technologies, Inc.
Hematology · 22d
Cleared Jan 25, 1990
FACTOR II DEFICIENT PLASMA
K900133 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 15d
Cleared Jan 25, 1990
HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE
K900150 · BYD
Icor AB
Anesthesiology · 14d
Cleared Jan 24, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892300 · LYY
Ryoden Intl., Ltd.
General Hospital · 293d
Cleared Jan 24, 1990
PATIENT EXAM GLOVES (MFG JET FAR INDU. INC.)
K893027 · LYY
Wen Hao, Inc.
General Hospital · 287d
Cleared Jan 24, 1990
PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED
K894555 · CCQ
Dura Pharmaceuticals, Inc.
Anesthesiology · 188d
Cleared Jan 24, 1990
SURGICAL GLOVES
K895080 · FGO
Jet Far Industries, Inc.
Gastroenterology & Urology · 163d
Cleared Jan 24, 1990
PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN
K895387 · BYJ
Puritan Bennett Corp.
Anesthesiology · 147d
Cleared Jan 24, 1990
SURGEON'S GLOVES
K895823 · KGO
Guey Her Ent. Co. , Ltd.
General Hospital · 117d
Cleared Jan 24, 1990
PROGUARD II(TM)
K896086 · FMF
Safety-Ject, Inc.
General Hospital · 97d