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
102793–102816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1995
TELPHONIC STETHOSCOPE
K945638 · DQD
American Telecare, Inc.
Cardiovascular · 182d
Cleared May 17, 1995
VANGUARD
K946084 · FMI
Vanguard Container Corp.
General Hospital · 155d
Cleared May 17, 1995
1700 MONITORING ECG ELECTRODE
K946273 · DRX
Conmed Andover Medical, Inc.
Cardiovascular · 146d
Cleared May 17, 1995
OPTA 5(TM) 5F PTA BALLOON CATHETER
K950119 · LIT
Cordis Corp.
Cardiovascular · 126d
Cleared May 17, 1995
MED-SURG SUTURE WASHER
K950250 · HWC
Medical Surgical, Inc.
Orthopedic · 114d
Cleared May 17, 1995
ALPHA SYSTEM
K950312 · JDI
Zimmer, Inc.
Orthopedic · 111d
Cleared May 17, 1995
GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE
K950486 · DRX
Graphic Controls Corp.
Cardiovascular · 100d
Cleared May 17, 1995
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
K950487 · DRX
Graphic Controls Corp.
Cardiovascular · 100d
Cleared May 17, 1995
PICIS CHART+
K950536 · MHX
Picis
Cardiovascular · 99d
Cleared May 17, 1995
BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR
K950663 · GEI
Bei Medical Systems Co., Inc.
General & Plastic Surgery · 93d
Cleared May 17, 1995
AIRGUIDE STYLETTE
K950713 · BSR
Polamedco, Inc.
Anesthesiology · 91d
Cleared May 17, 1995
PULSE*SPRAY INFUSION SYSTEM
K950907 · QEY
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 93d
Cleared May 17, 1995
ASH-7000
K951228 · ITH
U.S. Table, Inc.
Physical Medicine · 58d
Cleared May 17, 1995
STONE DISLODGER, BASKET
K951309 · FGO
Boston Scientific Corp
Gastroenterology & Urology · 56d
Cleared May 17, 1995
SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY
K951450 · KIJ
Strenumed, Inc.
Orthopedic · 49d
Cleared May 17, 1995
ASSURE, SELF-SEALING STERILIZATION POUCH
K951590 · KCT
Sultan Chemists, Inc.
General Hospital · 41d
Cleared May 17, 1995
IMX ESTRADIOL
K951629 · JIS
Abbott Laboratories
Chemistry · 61d
Cleared May 17, 1995
WELCH ALLYN HI - LUX ILLUMINATOR
K951647 · FCW
Welch Allyn, Inc.
Gastroenterology & Urology · 37d
Cleared May 17, 1995
PROFEEL
K951661 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 37d
Cleared May 17, 1995
COMFIT/BEADED SURGEON'S GLOVE
K951662 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 37d
Cleared May 17, 1995
COMFIT/GREEN POWDERED EXAMINATION GLOVES
K951667 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 37d
Cleared May 17, 1995
SCIPOTEX/POWDER FREE EXAMINATION GLOVES
K951668 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 37d
Cleared May 16, 1995
EXETER INTRAMEDULLARY BONE PLUG
K933077 · LZN
Howmedica Corp.
Orthopedic · 692d
Cleared May 16, 1995
TS1 TURTLE(TM) SYRINGE
K936225 · MEG
Kershenstine Diamond, Inc.
General Hospital · 512d