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

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176,076 results
165025–165048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1981
NORMLCERA
K810268 · KIS
Medical Specialties Laboratories
Chemistry · 32d
Cleared Mar 06, 1981
ACRYTOL, MOUNTING MEDIUM
K810323 · KEP
Surgipath
Pathology · 28d
Cleared Mar 06, 1981
PRE-VAP CAPS
K810394 · JJC
Sherman Boosalis
Chemistry · 16d
Cleared Mar 06, 1981
EMIT-ST SERUM BENZODIAZEPINE ASSAY
K810463 · JXM
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
EMIT-ST SERUM CALBRATOR
K810464 · DKB
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
EMIT-ST ETHYL ALCOHOL SERUM CONTROLS
K810465 · DKC
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
ETHYL ALCOHOL SERUM CALIBRATOR
K810466 · DNN
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
EMIT-ST SERUM ETHYL ALCOHOL ASSAY
K810467 · DMT
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
EMIT-ST SERUM CONTROLS
K810468 · DIF
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
DIGITAL DISPENSING PUMP
K810509 · JQW
Dynatech Corp.
Chemistry · 10d
Cleared Mar 06, 1981
BECKMAN DU-8 SPECTROPHOTOMETER
K810511 · JJQ
Beckman Instruments, Inc.
Chemistry · 10d
Cleared Mar 06, 1981
NEO-WAVE SYSTEM
K810543 · INX
Gaymar Industries, Inc.
Physical Medicine · 7d
Cleared Mar 05, 1981
CPS-1000
K802890 · DTN
Gics Pharmaceuticals
Cardiovascular · 108d
Cleared Mar 05, 1981
MARK 500 SYSTEM
K810073 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 51d
Cleared Mar 05, 1981
PHERESIS NEEDLE ASSEMBLY
K810076 · GAA
Haemonetics Corp.
General & Plastic Surgery · 51d
Cleared Mar 05, 1981
AM 420 MICROPROCESSOR
K810163 · DXG
Honeywell, Inc.
Cardiovascular · 42d
Cleared Mar 05, 1981
PROXIMAL FERMORAL HIP REPLACEMENT
K810258 · JDO
Biomet, Inc.
Orthopedic · 34d
Cleared Mar 05, 1981
FANCY TAN SUNBED
K810366 · LEJ
Fancy Tan, Inc.
Radiology · 21d
Cleared Mar 05, 1981
MEADOX SZILAGYI GRAFT
K810376 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 21d
Cleared Mar 05, 1981
PRE-BYPASS FILTER
K810395 · KRJ
Texas Medical Products, Inc.
Cardiovascular · 15d
Cleared Mar 05, 1981
STERILE PACKAGING
K810410 · DXY
Telectronics, Inc.
Cardiovascular · 15d
Cleared Mar 05, 1981
USCI CARDIOVASCULAR CATHETER
K810412 · DQO
C.R. Bard, Inc.
Cardiovascular · 15d
Cleared Mar 05, 1981
SARNS MINI-SUCKER
K810416 · GCY
3M Health Care, Sarns
General & Plastic Surgery · 15d
Cleared Mar 04, 1981
OPTION 301 PACEMAKER EVAL. MODULE MAC-1
K802368 · DPS
Marquette Electronics, Inc.
Cardiovascular · 156d