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
128041–128064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1989
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
K894939 · FPD
North American Sterilization &...
Gastroenterology & Urology · 127d
Cleared Dec 08, 1989
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
K895473 · GZJ
Medical Devices, Inc.
Neurology · 88d
Cleared Dec 08, 1989
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
K895502 · EPP
Microbio-Medics, Inc.
Ear, Nose, Throat · 87d
Cleared Dec 08, 1989
CALASEPT PASTE
K895508 · EJK
Js Dental Mfg., Inc.
Dental · 88d
Cleared Dec 08, 1989
PHASE II ORTHODONTIC ADHESIVE
K895523 · DYH
Reliance Orthodontic Products, Inc.
Dental · 87d
Cleared Dec 08, 1989
B-D PEND NEEDLE
K895630 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 80d
Cleared Dec 08, 1989
HEMOSTAT/STIMULATOR PROBE
K895676 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 79d
Cleared Dec 08, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
K895707 · LLM
Immuno Concepts, Inc.
Microbiology · 74d
Cleared Dec 08, 1989
WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT
K896069 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 08, 1989
1.2 MICRON FILTER WITH IV SET
K896292 · FPB
Kendall Mcgaw Laboratories, Inc.
General Hospital · 38d
Cleared Dec 08, 1989
VENTREZYME VAST SPECIFIC IGE ASSAY
K896694 · DHB
Ventrex Laboratories, Inc.
Immunology · 10d
Cleared Dec 07, 1989
CATHETER, CARDIOVASCULAR, BALLOON TYPE
K883852 · DXE
Wb Intl., Inc.
Cardiovascular · 450d
Cleared Dec 07, 1989
RMI CARDIOPLEGIA DELIVERY SETS
K892368 · DTL
Research Medical, Inc.
Cardiovascular · 245d
Cleared Dec 07, 1989
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
K892377 · DTL
Research Medical, Inc.
Cardiovascular · 245d
Cleared Dec 07, 1989
CORTISOL TEST SYSTEM
K895421 · JFT
Baxter Healthcare Corp
Chemistry · 97d
Cleared Dec 07, 1989
RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)
K895521 · DYH
Reliance Orthodontic Products, Inc.
Dental · 86d
Cleared Dec 07, 1989
LIGHT BOND PASTE W/FLUORIDE
K895522 · DYH
Reliance Orthodontic Products, Inc.
Dental · 86d
Cleared Dec 07, 1989
K-1 INFANT TRANSPORT SYSTEM
K895550 · FMZ
K-1 Medical Products, Inc.
General Hospital · 85d
Cleared Dec 07, 1989
GLYCOTEST II GLYHB ASSAY KIT
K895661 · LCP
Pierce Chemical Co.
Hematology · 78d
Cleared Dec 07, 1989
DIATEK MODEL 700 THERMOMETER
K895703 · FLL
Diatek, Inc.
General Hospital · 76d
Cleared Dec 07, 1989
MILLAR MIKRO-TIP PULSE TRANSDUCER
K895721 · DXO
Millar Instruments, Inc.
Cardiovascular · 73d
Cleared Dec 07, 1989
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · CBK
Quinton, Inc.
Anesthesiology · 91d
Cleared Dec 07, 1989
NEONATAL INCUBATOR (ACCESSORY)
K895782 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 71d
Cleared Dec 07, 1989
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789 · LDF
Medtronic Vascular
Cardiovascular · 70d