FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136033–136056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 06, 1988
MULTICOR AND PACEMAKERS
K880898 · DXY
Tpl-Cordis, Inc.
Cardiovascular · 70d
Cleared May 06, 1988
BARD (R) ESKA ERECTIOMETER
K880903 · LIL
C.R. Bard, Inc.
Gastroenterology & Urology · 65d
Cleared May 06, 1988
NATELSON TUBES, HEPARIN AND PLAIN
K881187 · GIO
Helps Products, Inc.
Hematology · 46d
Cleared May 06, 1988
CARAWAY TUBES, HEPARIN AND PLAIN
K881262 · GIO
Helps Products, Inc.
Hematology · 43d
Cleared May 06, 1988
CLP ABNORMAL COAGULATION CONTROL
K881510 · GGC
Creative Laboratory Products, Inc.
Hematology · 25d
Cleared May 06, 1988
HR(TM) INTRAVASCULAR CATHETER
K881666 · FOZ
Icu Medical, Inc.
General Hospital · 18d
Cleared May 04, 1988
CADWELL EXCEL
K880088 · GWF
Cadwell Laboratories, Inc.
Neurology · 113d
Cleared May 04, 1988
SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650
K880519 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650
K880521 · IZO
Fischer Imaging Corp.
Radiology · 85d
Cleared May 04, 1988
THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80
K880522 · IZO
Fischer Imaging Corp.
Radiology · 85d