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
133969–133992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1988
IQ HDL CHOLESTEROL
K883353 · LBR
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Sep 13, 1988
HANDSWITCHING MONOPOLAR PENCIL
K883396 · GEI
New England Surgical Instrument Corp.
General & Plastic Surgery · 33d
Cleared Sep 13, 1988
URIC ACID REAGENT (PRODUCT #88219)
K883404 · KNK
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 13, 1988
TRIGLYCERIDES REAGENT (PRODUCT #88218)
K883405 · CDT
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 13, 1988
BIOTROL URIC ACID ENZYMATIQUE TRINDER
K883428 · KNK
Biotrol, USA, Inc.
Chemistry · 29d
Cleared Sep 13, 1988
VISION(R) PROTHROMBIN TIME
K883441 · GJS
Abbott Laboratories
Hematology · 29d
Cleared Sep 13, 1988
THORACIC CATHETERS
K883474 · GBX
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 28d
Cleared Sep 13, 1988
STRYKER PRESSURE MONITOR SYSTEM
K883485 · FTY
Stryker Corp.
General & Plastic Surgery · 28d
Cleared Sep 13, 1988
DURAZYME(R) CPK
K883504 · CGS
American Monitor Corp.
Chemistry · 27d
Cleared Sep 13, 1988
S 21 INSTRUMENT STAND
K883578 · FSH
Carl Zeiss, Inc.
General & Plastic Surgery · 22d
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