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
167305–167328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1980
WRIGHTS RAPID STAIN
K801212 · IAF
Mcb Manufacturing Chemists, Inc.
Hematology · 10d
Cleared May 30, 1980
HAMILTON TUCKAWAY DESK
K801214 · KNO
Orthopedic Systems, Inc.
Physical Medicine · 10d
Cleared May 30, 1980
SKIL-CARE GEL WEDGE, FLOTATION PAD
K801217 · KIC
Skil-Care Corp.
Physical Medicine · 9d
Cleared May 28, 1980
PERM. INPLANT ENDOCARD. PAC. LEAD
K800347 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
UNIPOLAR LEAD CONFIGURATION CONDUCTOR
K800348 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
ENDOCARD. PACING LEAD LONG LENGTH PL200
K800349 · DTB
Diag Corp.
Cardiovascular · 103d
Cleared May 28, 1980
ENDOCARD. PACING LEAD STD. LENGTH PL202
K800350 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PACEMAKER, ELECTRODE, PERM. & TEMP.
K800351 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PACEMAKER, ELECTRODE
K800352 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
ADAPTER KIT
K800353 · DTD
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
LEAD, SUTURELESS MYOCARDIAL
K800355 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
PERMANENT LEAD INTRADUCER
K800356 · DYB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
K800672 · CDH
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
K800673 · CDW
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER
K800674 · CEK
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. TOTAL BILIRUBIN
K800675 · CIG
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. SODIUM IN HUMAN SUM
K800676 · JGS
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. SERUM IRON IN HUMAN
K800677 · JIY
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. ALBUMIN IN HUMAN
K800678 · CIX
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. ALKALINE PHOSPHATAS
K800679 · CJE
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. CALCIUM IN HUMAN
K800680 · CIC
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENTS FOR DETERM. CHOLESTEROL/SERUM
K800682 · CGO
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM
K800683 · CHJ
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared May 28, 1980
REAGENT FOR DETERM. CREATINE PHOSPHOKINA
K800684 · JHY
Diagnostic Solutions, Inc.
Chemistry · 63d