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
150721–150744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1984
SERVOMED BASIC BEDSIDE UNIT SMV 110TP
K840524 · DRT
Litton Medical Electronics
Cardiovascular · 262d
Cleared Oct 26, 1984
INSTANT REPLAY
K840587 · DXH
Instromedix, Inc.
Cardiovascular · 261d
Cleared Oct 26, 1984
CARDIOTRODE
K840646 · DRX
Kholber Corp.
Cardiovascular · 254d
Cleared Oct 26, 1984
NONINVASIVE BLOOD PRESSURE MEASURE SYS
K841103 · DXN
Panasonic Co. Div. Matsu Elec. Corp....
Cardiovascular · 226d
Cleared Oct 26, 1984
NON-INVASIVE BP MODULE 7000
K841336 · DXN
Marquette Electronics, Inc.
Cardiovascular · 207d
Cleared Oct 26, 1984
GIL-MED PARENTERAL NUTRITION OR MEDICINE
K841597 · KPE
Gil-Med Industries C/O Kegan & Kegan,...
General Hospital · 191d
Cleared Oct 26, 1984
TRANSDUCER-MONITOR INTERFACING
K842150 · DXO
Millar Instruments, Inc.
Cardiovascular · 149d
Cleared Oct 26, 1984
VSM R1
K842213 · DXO
Physio-Control Corp.
Cardiovascular · 144d
Cleared Oct 26, 1984
IMPLANTABLE PROGRAMMABLE PULSE GENERAT
K842473 · DXY
Telectronics, Inc.
Cardiovascular · 123d
Cleared Oct 26, 1984
ORTHOPAEDIC CABLE SYSTEM
K842977 · JDQ
Richards Medical Co., Inc.
Orthopedic · 88d
Cleared Oct 26, 1984
AEGIS AMBULATORY MONITORING SYSTEM
K843503 · DSI
Aegis Medical Systems, Inc.
Cardiovascular · 50d
Cleared Oct 26, 1984
J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI
K843830 · GDM
Popper & Sons, Inc.
General & Plastic Surgery · 25d
Cleared Oct 26, 1984
CUSTOM INSTRUMENT DRAPE
K843890 · HMW
Lifestream Int'L, Inc.
General Hospital · 24d
Cleared Oct 25, 1984
DIGISTORE 50
K842191 · JAA
Vas Corp.
Radiology · 143d
Cleared Oct 25, 1984
SERATEST DNA DETERMINATION
K842563 · LKJ
Seragen Diagnostics, Inc.
Immunology · 115d
Cleared Oct 25, 1984
SUTURE STRIP
K842621 · FPX
Genetic Laboratories, Inc.
General & Plastic Surgery · 112d
Cleared Oct 25, 1984
UNIFLOW VENT TUBE
K842637 · ETD
Richards Medical Co., Inc.
Ear, Nose, Throat · 108d
Cleared Oct 25, 1984
BONE MILL BONE GRINDER
K842845
Acromed Corp.
General & Plastic Surgery · 97d
Cleared Oct 25, 1984
HAYFEVER HELMET
K842973 · FRF
R.H. Hinchli Fle & Sons, Ltd.
General Hospital · 87d
Cleared Oct 25, 1984
KERR PORCELAIN REPAIR PRIMER
K843023 · KLE
Kerr Corporation (Danbury)
Dental · 85d
Cleared Oct 25, 1984
COMMAND ENAMEL-DENT DENTAL ADHESIVE
K843025 · KLE
Kerr Corporation (Danbury)
Dental · 85d
Cleared Oct 25, 1984
ANATOM SYSTEM
K843233 · KLC
Lic-Orthion
Dental · 69d
Cleared Oct 25, 1984
CITOMAT AUTOCLAVES
K843234 · ECG
Lic-Orthion
Dental · 69d
Cleared Oct 25, 1984
RESTODENT VL
K843363 · EBF
Lee Pharmaceuticals
Dental · 58d