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
160849–160872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1982
LITERATURE ON THE SONADENT
K827410
L&R Mfg. Co., Inc.
Radiology · 35d
Cleared Jun 03, 1982
PRE-STERILIZATION OF VITALLIUM ALLOY
K820218
Howmedica Corp.
Orthopedic · 128d
Cleared Jun 03, 1982
SEAMED, #540 - SIEMENS, #146F TELECTRO
K820570 · DTE
Seamed Corp.
Cardiovascular · 93d
Cleared Jun 03, 1982
THERATRONIC STIMULATOR
K820782 · IPF
Theratronics, Inc.
Physical Medicine · 72d
Cleared Jun 03, 1982
KEY DRILL
K821127 · GFG
Key Medical, Inc.
General & Plastic Surgery · 44d
Cleared Jun 03, 1982
MAYO-HEGAR NEEDLE HOLDER
K821289 · GDF
Conphar, Inc.
General & Plastic Surgery · 30d
Cleared Jun 03, 1982
OLSEN HEGAR NEEDLE HOLDERS
K821295 · GDF
Conphar, Inc.
General & Plastic Surgery · 30d
Cleared Jun 03, 1982
IOI METAL BACKED TIBIAL COMPONENT
K821341 · HRY
Intermedics Orthopedics
Orthopedic · 29d
Cleared Jun 03, 1982
BDH FEMORAL COMPONENT
K821343 · KWL
Intermedics Orthopedics
Orthopedic · 29d
Cleared Jun 03, 1982
CONPHAR MAYO HEGAR NEEDLE HOLDER
K821354 · GDF
Conphar, Inc.
General & Plastic Surgery · 29d
Cleared Jun 03, 1982
SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER
K821394 · MMK
Kleen Test Products
General Hospital · 23d
Cleared Jun 03, 1982
SADDLEBAG INSTRUMENT PAD W/POUCHES
K821395
Kleen Test Products
General Hospital · 23d
Cleared Jun 03, 1982
ULTRACHEM CREA #64972
K821472
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
ULTRAZYME PLUS CKI, #64978,65027&65028
K821473 · CGS
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
ULTRACHEM URIC ACID AIDH #65047
K821474 · CDO
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
RIA STAT 16
K821494 · JJJ
E. R. Squibb & Sons, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
IRIS URINE STAIN
K821503 · ICF
Intl. Remote Imaging Systems
Pathology · 15d
Cleared Jun 03, 1982
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA
K821542 · LCR
Electro-Nucleonics Laboratories, Inc.
Toxicology · 10d
Cleared Jun 03, 1982
IPA FOR DETECTION OF PHENOBARBITAL
K821543 · LFN
Electro-Nucleonics Laboratories, Inc.
Toxicology · 10d
Cleared Jun 03, 1982
ORTHOPEDIC FIXATION DEVICES
K821566 · KTW
Howmedica Corp.
Orthopedic · 9d
Cleared Jun 03, 1982
PNEUMO PULSSOR III
K821570 · BYI
Strom Corp.
Anesthesiology · 7d
Cleared Jun 02, 1982
UNIFLEX
K820470 · NAB
Howmedica Corp.
General & Plastic Surgery · 100d
Cleared Jun 02, 1982
SURGIKOS INCISE DRAPE
K820542 · KKX
Surgikos, Inc.
General Hospital · 92d
Cleared Jun 02, 1982
RADIOIMMUNOASSAY PARATHYROID HORMONE MID
K821131 · CEW
Endocrine-Metabolic Center
Chemistry · 43d