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
145873–145896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1985
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD
K854405 · DTB
Pacesetter Systems
Cardiovascular · 33d
Cleared Dec 04, 1985
CK(OPTIMIZED) REAGENT
K854501 · CGS
Sigma Diagnostics, Inc.
Chemistry · 22d
Cleared Dec 03, 1985
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
K851365 · DXY
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 242d
Cleared Dec 03, 1985
PMA PRESSURE MONITOR
K852824 · CAP
Ferguson Medical
Anesthesiology · 155d
Cleared Dec 03, 1985
TMA TEMPERATURE MONITOR
K852825 · FLL
Ferguson Medical
General Hospital · 155d
Cleared Dec 03, 1985
AN PRESSURE MONITOR
K852826 · CAP
Ferguson Medical
Anesthesiology · 154d
Cleared Dec 03, 1985
L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION
K853099 · DTL
L.O.N. Research, Inc.
Cardiovascular · 133d
Cleared Dec 03, 1985
MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)
K853136 · MAV
E.A. Fischione Instrument Mfg.
Cardiovascular · 130d
Cleared Dec 03, 1985
CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
K853383 · DYG
Webster Laboratories, Inc.
Cardiovascular · 113d
Cleared Dec 03, 1985
TENS CONDUCTIVE MEDIA PAD
K853633 · GXY
Alternative Design Systems, Inc.
Neurology · 95d
Cleared Dec 03, 1985
PY-RITE
K853758 · NJH
Golden Dental Products, Inc.
Ophthalmic · 85d
Cleared Dec 03, 1985
ADULT VENTILATOR TESTER VT-1
K853760 · CBK
Bio-Tek Instruments, Inc.
Anesthesiology · 85d
Cleared Dec 03, 1985
SERIES 2000 MEDS MASK
K853785 · BSJ
Med Systems
Anesthesiology · 84d
Cleared Dec 03, 1985
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI
K853914 · DTB
Pacesetter Systems
Cardiovascular · 71d
Cleared Dec 03, 1985
NEOGUARD CHEST PERCUSSOR
K853965 · BYI
Cas Medical Systems, Inc.
Anesthesiology · 68d
Cleared Dec 03, 1985
AMERICAN PHARMASEAL HUMIDAIR CONDENSER
K854012 · BYD
American Pharmaseal Div. Ahsc
Anesthesiology · 64d
Cleared Dec 03, 1985
COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS
K854132 · DXY
Cook Pacemaker Corp.
Cardiovascular · 54d
Cleared Dec 03, 1985
ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC
K854137 · DQY
Arrow Intl., Inc.
Cardiovascular · 54d
Cleared Dec 03, 1985
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE
K854214 · DXY
Cordis Corp.
Cardiovascular · 47d
Cleared Dec 03, 1985
HEADSTRAP
K854537 · BTK
Life Design Systems, Inc.
Anesthesiology · 20d
Cleared Dec 02, 1985
SONOLAYER-L, SAL-77A
K852090 · ITX
Toshiba Medical Systems
Radiology · 203d
Cleared Dec 02, 1985
NEW OPTIONAL PROBES FOR SSA-90A
K852159 · ITX
Toshiba Medical Systems
Microbiology · 199d
Cleared Dec 02, 1985
FOUR CHANNEL PH PROBE
K853280 · FFT
Akron City Hospital
Gastroenterology & Urology · 119d
Cleared Dec 02, 1985
FLOSPIK
K853767 · JES
Medelco , Ltd.
Dental · 84d