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
135433–135456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1988
INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER
K881745 · LJT
Shiley Infusaid, Inc.
General Hospital · 19d
Cleared May 11, 1988
MODIFIED MODEL 2100 ND:YAG LASER
K881848 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 9d
Cleared May 10, 1988
PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K874917 · DXN
Oxford Medilog, Inc.
Cardiovascular · 159d
Cleared May 10, 1988
AIDS SAFETY BELT
K875068 · HIS
Aids Safety Belt, Inc.
Obstetrics & Gynecology · 154d
Cleared May 10, 1988
OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
K880572 · DXN
Ohmeda Medical
Cardiovascular · 89d
Cleared May 10, 1988
LARGE LUMEN Y ADAPTER W/ROTATING DEVICE
K880831 · DTL
Interventional Medical, Inc.
Cardiovascular · 70d
Cleared May 09, 1988
(MB-650) BLOOD PRESSURE MONITOR
K880715 · DXN
Sharp Electronics Corp.
Cardiovascular · 90d
Cleared May 09, 1988
MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY
K880779 · DWF
Medsurg Industries, Inc.
Cardiovascular · 73d
Cleared May 09, 1988
ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
K881618 · FXX
3M Company
General Hospital · 24d
Cleared May 06, 1988
ABBOTT TESTPACK RSV
K874127 · GQG
Abbott Laboratories
Microbiology · 206d
Cleared May 06, 1988
CATHRA GRAM POSITIVE SCREEN
K874606 · LQL
Mct Medical, Inc.
Microbiology · 179d
Cleared May 06, 1988
DETECTADOT SYSTEM 2000 CMV IGG TEST
K875159 · GQI
Gull Laboratories, Inc.
Microbiology · 142d
Cleared May 06, 1988
LAMINARIA
K880196 · HDY
Medgyn Products, Inc.
Obstetrics & Gynecology · 101d
Cleared May 06, 1988
LCS FEMORAL HIP PROSTHESIS
K880269 · JDI
Depuy, Inc.
Orthopedic · 106d
Cleared May 06, 1988
NEOTECH MECONIUM ASPIRATOR (STERILE)
K880487 · BTR
Neotech Products, Inc.
Anesthesiology · 92d
Cleared May 06, 1988
VSM(R) R2 PAPER CHART RECORDER
K880554 · DSF
Physio-Control Corp.
Cardiovascular · 87d
Cleared May 06, 1988
HORIZON 2000/S 266-XXX-XXX
K880595 · DPS
Mennen Medical, Inc.
Cardiovascular · 85d
Cleared May 06, 1988
WIRE PASS DRILL BITS
K880601 · HBE
Nuell Air Equipment & Hospital...
Neurology · 85d
Cleared May 06, 1988
ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)
K880644 · IRQ
Fred Sammons, Inc.
Physical Medicine · 80d
Cleared May 06, 1988
MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER
K880671 · DTM
Medtronic Blood Systems, Inc.
Cardiovascular · 78d
Cleared May 06, 1988
SENTINEL PULSE OXIMETER
K880672 · DQA
Sentinel Monitoring Technologies, Ltd.
Anesthesiology · 77d
Cleared May 06, 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
K880698 · LCP
Helena Laboratories
Hematology · 74d
Cleared May 06, 1988
CLP NORMAL COAGULATION CONTROL
K880712 · GIZ
Creative Laboratory Products, Inc.
Hematology · 74d
Cleared May 06, 1988
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
K880821 · LIQ
Abbott Laboratories
Microbiology · 66d