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
144481–144504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1986
OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER
K861166 · CAN
Victor
Anesthesiology · 4d
Cleared Apr 01, 1986
NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
K861170 · BSZ
Draeger Medical, Inc.
Anesthesiology · 4d
Cleared Mar 31, 1986
UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762
K852973 · DXY
Ela Medical, Inc.
Cardiovascular · 259d
Cleared Mar 31, 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669 · DSI
Hewlett-Packard Co.
Cardiovascular · 209d
Cleared Mar 31, 1986
SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER
K854319 · LIT
Shiley, Inc.
Cardiovascular · 154d
Cleared Mar 31, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
K854830 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 118d
Cleared Mar 31, 1986
VALVOKIT
K854831 · DYB
Novamed Products, Inc.
Cardiovascular · 118d
Cleared Mar 31, 1986
CUP MONITORING KIT CVPK-14
K854984 · DQY
Medical Components, Inc.
Cardiovascular · 109d
Cleared Mar 31, 1986
NONINVASIVE TEMP. PACEMAKER NTP-1000
K855015 · DRO
Zmi Corp.
Cardiovascular · 105d
Cleared Mar 31, 1986
DEFIB-PADS
K855082 · LDD
Conmedcorp
Cardiovascular · 102d
Cleared Mar 31, 1986
SIMMONS SHELL
K855105 · HQT
Mira, Inc.
Ophthalmic · 98d
Cleared Mar 31, 1986
FUKUDA DENSHI CARDIMAX FCP-211
K860024 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 87d
Cleared Mar 31, 1986
VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015
K860149 · DWF
Dlp, Inc.
Cardiovascular · 75d
Cleared Mar 31, 1986
PRODIGY AND PRODIGY PLUS
K860167 · DSI
Cardiodata Corp.
Cardiovascular · 73d
Cleared Mar 31, 1986
AMI CARDIO-PAD
K860283 · DRO
Andover Medical, Inc.
Cardiovascular · 62d
Cleared Mar 31, 1986
TUBING CONNECTORS
K860291 · DTL
Biomedical Exports, Inc.
Cardiovascular · 62d
Cleared Mar 31, 1986
PERCUTANEOUS CATHETERS
K860339 · DQY
Micor, Inc.
Cardiovascular · 61d
Cleared Mar 31, 1986
PERCUTANEOUS INTRODUCER KIT
K860432 · DYB
Cormed, Inc., Sub. C.R.Bard, Inc.
Cardiovascular · 55d
Cleared Mar 31, 1986
(.O38) HI-TORQUE GUIDE WIRES
K860533 · DQX
Target Therapeutics
Cardiovascular · 47d
Cleared Mar 31, 1986
ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE
K860570 · KRA
Parke-Davis Co.
Cardiovascular · 45d
Cleared Mar 31, 1986
ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
K860580 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d
Cleared Mar 31, 1986
OPTHALMIC SURGICAL INSTRUMENTS
K860744 · HMX
Tridak Division of Indicon, Inc.
Ophthalmic · 32d
Cleared Mar 31, 1986
REGULATED PRESSURE INJECTOR
K860806 · DXF
Target Therapeutics
Cardiovascular · 27d
Cleared Mar 31, 1986
MODEL 366-08 ADAPTAID CONNECTOR ADAPTER
K860832 · DTD
Intermedics, Inc.
Cardiovascular · 26d