Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
59641–59664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2007
SUPERSTAR 0.35T MRI SYSTEM
K071154 · LNH
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared May 09, 2007
ACCU-CHEK SMART PIX
K062395 · NBW
Roche Diagnostics Corp.
Chemistry · 266d
Cleared May 09, 2007
LMA STONEBREAKER DEVICE
K062475 · FFK
The Laryngeal Mask Co., Ltd.
Gastroenterology & Urology · 258d
Cleared May 09, 2007
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
K062943 · OLZ
Neurotronics, Inc.
Neurology · 223d
Cleared May 09, 2007
POGS, MODEL 33C
K063454 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 175d
Cleared May 09, 2007
STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL...
K063584 · HWC
Regeneration Technologies, Inc.
Orthopedic · 159d
Cleared May 09, 2007
SHARPOINT PDO (POLYDIOXANONE) SUTURES
K063680 · NEW
Surgical Specialties Corp
General & Plastic Surgery · 149d
Cleared May 09, 2007
COLIN PRESS MATE, MODEL BP S510
K063690 · MHX
Omron Healthcare, Inc.
Cardiovascular · 148d
Cleared May 09, 2007
PRO-DENSE BONE VOID FILLER
K070437 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 83d
Cleared May 09, 2007
AURAVUE PIT & FISSURE SEALANT
K070693 · EBF
Denali Corporation
Dental · 57d
Cleared May 09, 2007
SYNEPIX 4600 DETECTOR
K070829 · MQB
Analogic Corporation
Radiology · 44d
Cleared May 09, 2007
TOPAS SYSTEM
K070993 · FTL
American Medical Systems, Inc.
General & Plastic Surgery · 30d
Cleared May 09, 2007
EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
K070994 · KWQ
Depuy Spine, Inc.
Orthopedic · 30d
Cleared May 09, 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K071008 · NCX
Radiant Medical
Neurology · 30d
Cleared May 08, 2007
RESONANCE METALLIC URETERAL STENT
K063742 · FAD
Cook Ireland, Ltd.
Gastroenterology & Urology · 141d
Cleared May 08, 2007
BIPAP SYNCHRONY WITH AVAPS
K070328 · MNS
Respironics Inc., Sleep & Home...
Anesthesiology · 92d
Cleared May 08, 2007
METASURG SUBTALAR IMPLANT
K070441 · HWC
Metasurg
Orthopedic · 82d
Cleared May 08, 2007
AFF (MARK I) VOLUMETRIC INFUSION PUMP
K070529 · FRN
Definitive Medical Technologies, Ltd.
General Hospital · 74d
Cleared May 08, 2007
INTERWORKS
K070755 · LLZ
Avreo, Inc.
Radiology · 50d
Cleared May 08, 2007
MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
K070830 · HIS
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 43d
Cleared May 08, 2007
4 FR SINGLE LUMEN (SL) POWERPICC CATHETER
K070996 · LJS
C.R. Bard, Inc.
General Hospital · 29d
Cleared May 08, 2007
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR...
K071106 · KIF
Ultradent Products, Inc.
Dental · 19d
Cleared May 08, 2007
SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM
K071134 · IYO
Sonosite,Inc.
Radiology · 15d
Cleared May 08, 2007
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
K071162 · MQB
Agfa Healthcare Corp.
Radiology · 12d