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
134569–134592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1988
OPMI CS
K883581 · EPT
Carl Zeiss, Inc.
General & Plastic Surgery · 22d
Cleared Sep 13, 1988
805 POWER CHAIR CONVERSION SYSTEM
K883671 · ITI
Rolcontrol Products, Co., Inc.
Physical Medicine · 26d
Cleared Sep 13, 1988
PARALYZED VETERANS OF AMERICA POWER RECLINER
K883672 · ITI
Rolcontrol Products, Co., Inc.
Physical Medicine · 26d
Cleared Sep 13, 1988
POWER MECHANICAL RECLINER
K883673 · ITI
Rolcontrol Products, Co., Inc.
Physical Medicine · 26d
Cleared Sep 13, 1988
MANUAL SWING ARM
K883674 · ITI
Rolcontrol Products, Co., Inc.
Physical Medicine · 26d
Cleared Sep 13, 1988
4007 MODEL RECLINER CONTROLLER
K883678 · ITI
Rolcontrol Products, Co., Inc.
Physical Medicine · 26d
Cleared Sep 13, 1988
WHEELS-OFF QUICK RELEASE AXLE SYSTEM
K883679 · KNN
Rolcontrol Products, Co., Inc.
Physical Medicine · 26d
Cleared Sep 12, 1988
TRU-TRAC COILED GUIDEWIRE
K880287 · DQX
N-S Medical Products
Cardiovascular · 231d
Cleared Sep 12, 1988
TRU-TRAC TORQUE GUIDEWIRE
K880288 · DQX
N-S Medical Products
Cardiovascular · 231d
Cleared Sep 12, 1988
BRADBURY INTRAOCULAR RETINAL KIT CAT #200
K881049 · HNR
Microline Pentax, Inc.
Ophthalmic · 185d
Cleared Sep 12, 1988
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · FER
Baxter Healthcare Corp
Gastroenterology & Urology · 158d
Cleared Sep 12, 1988
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
K882474 · DXY
Ela Medical, Inc.
Cardiovascular · 89d
Cleared Sep 12, 1988
OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
K882476 · DXY
Ela Medical, Inc.
Cardiovascular · 89d
Cleared Sep 12, 1988
COLLAGEN SHIELD
K882762 · MOE
Chiron Ophthalmics
Ophthalmic · 68d
Cleared Sep 12, 1988
PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)
K882879 · DXC
Pioneering Technologies, Inc.
Cardiovascular · 63d
Cleared Sep 12, 1988
MX860, REUSABLE PRESSURE TRANSDUCER
K883095 · DRS
Medex, Inc.
Cardiovascular · 52d
Cleared Sep 12, 1988
MULTINEX MONITOR (MODIFICATION)
K883254 · CCL
Datascope Corp.
Anesthesiology · 41d
Cleared Sep 12, 1988
HEARTSTART 1000
K883341 · MKJ
Laerdal Mfg. Corp.
Cardiovascular · 34d
Cleared Sep 12, 1988
HEARTSTART 1000S
K883344 · MKJ
Laerdal Mfg. Corp.
Cardiovascular · 34d
Cleared Sep 12, 1988
RAYMAX 2100 MODELS 2130 & 2136
K883431 · IZO
Raymax Medical Corp.
Radiology · 28d
Cleared Sep 12, 1988
MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
K883575 · HMG
Site Microsurgical Systems, Inc.
Ophthalmic · 21d
Cleared Sep 09, 1988
URINE TOXICOLOGY STANDARD
K881320 · DKB
Verichem Laboratories, Inc.
Toxicology · 165d
Cleared Sep 09, 1988
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
K881616 · JXG
Progress Mankind Technology
Neurology · 150d
Cleared Sep 09, 1988
BIODYNAMICS AUTOTRANSFUSION RESERVOIR
K881631 · CAC
Biodynamics Corp.
Anesthesiology · 148d