FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75529–75552 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2002
WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
K020673 · GEX
Wave Form Mfg., Inc.
General & Plastic Surgery · 90d
Cleared May 30, 2002
SS MATRIX
K020732 · KGN
Cook Biotech, Inc.
General & Plastic Surgery · 85d
Cleared May 30, 2002
SURX RF SYSTEM
K020952 · MUK
Surx, Inc.
Gastroenterology & Urology · 66d
Cleared May 30, 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
MODIFICATION TO ENTEC PLASMA WANDS
K021364 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared May 30, 2002
TOESCO AQUA BLUE LED LIGHT CURING DEVICE
K021374 · EBZ
Toei Electric Co., Ltd.
Dental · 29d
Cleared May 30, 2002
ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
K021587 · DQY
Medtronic Vascular
Cardiovascular · 15d
Cleared May 30, 2002
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K021589 · DQY
Medtronic Vascular
Cardiovascular · 15d
Cleared May 30, 2002
DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
K021612 · FLL
Actherm, Inc.
General Hospital · 14d
Cleared May 30, 2002
DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
K021614 · FLL
Actherm, Inc.
General Hospital · 14d
Cleared May 29, 2002
MICRO-INDUCTION 1000 SYSTEM
K013615 · DPS
Harbinger Medical, Inc.
Cardiovascular · 205d
Cleared May 29, 2002
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162,...
K020646 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
K021384 · DIF
Bio-Rad
Chemistry · 27d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
K021411 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS...
K021414 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS...
K021415 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR...
K021439 · LZG
Animas Corp.
General Hospital · 23d
Cleared May 29, 2002
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K021577 · GEI
Neothermia Corp.
General & Plastic Surgery · 15d
Cleared May 28, 2002
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
K011461 · LDD
Access Cardiosystems, Inc.
Cardiovascular · 379d
Cleared May 28, 2002
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
K013687 · LRK
Steven K. Sue
Dental · 202d
Cleared May 28, 2002
SELECT STIM
K020637 · IPF
Care Rehab and Orthopaedic
Physical Medicine · 90d
Cleared May 28, 2002
KSEA SCB MEDIA CONTROL
K020640 · FTA
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 90d
Cleared May 28, 2002
EZ-SCOPE AN & EZ-SCOPE AN LITE
K020643 · IYX
Health Policy Resorters Group, LLC
Radiology · 90d