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
169921–169944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1979
HEEL GARD
K790954 · FRK
Fem-Gard, Inc.
General Hospital · 29d
Cleared Jun 20, 1979
COVER GARD
K790955 · FRK
Fem-Gard, Inc.
General Hospital · 29d
Cleared Jun 20, 1979
MIC-2000 QUAD INOCULUM TRAY
K790971 · JTC
Dynatech Laboratories, Inc.
Microbiology · 29d
Cleared Jun 20, 1979
MIC-2000 INOCULATOR TEMPLATE
K790974 · JTC
Dynatech Laboratories, Inc.
Microbiology · 28d
Cleared Jun 20, 1979
CAST BRACE COMPONENTS
K791057 · IQI
3M Company
Physical Medicine · 12d
Cleared Jun 20, 1979
BOUNDARY SPECIALTY GOWN
K791062 · FYA
Procter & Gamble Mfg. Co.
General Hospital · 12d
Cleared Jun 20, 1979
ACCU-SORB STERILE STOCKINETTES
K791070 · KKX
Medline Industries, Inc.
General Hospital · 8d
Cleared Jun 20, 1979
WRENCH
K791073 · HXC
Truth, Inc.
Orthopedic · 8d
Cleared Jun 20, 1979
MODELS 2411/2418 VENTRICULAR-INHIBITED
K791093 · DXY
Medtronic Vascular
Cardiovascular · 8d
Cleared Jun 15, 1979
WHOLEY OCCLUSION BALLOON CATHETER
K772011 · FOZ
Cook, Inc.
General Hospital · 598d
Cleared Jun 15, 1979
EMIT-D.A.U. PHENCYCLIDINE URINE LOW
K790398 · DLJ
Syva Co.
Toxicology · 109d
Cleared Jun 15, 1979
URINE MEDIUM CALIBRATOR
K790399 · DLJ
Syva Co.
Toxicology · 109d
Cleared Jun 15, 1979
URINE NEGATIVE CALIBRATOR
K790400 · DLT
Syva Co.
Toxicology · 109d
Cleared Jun 15, 1979
PHENCYCLIDINE URINE ASSAY
K790401 · LCM
Syva Co.
Toxicology · 109d
Cleared Jun 15, 1979
CHOLESTEROL KIT, HDL-DS
K790553 · LBS
Beckman Instruments, Inc.
Chemistry · 88d
Cleared Jun 15, 1979
AMES TDA/GENTGMICIN
K790584 · DJB
Miles Laboratories, Inc.
Toxicology · 80d
Cleared Jun 15, 1979
IMPRESSION MATERIAL, RUBBER
K790592 · ELW
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
DENTAL CEMENT, ZINC PHOSPHATE
K790593 · EMA
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
DENTAL COMPOSITE RESTORATIVE MATERIAL
K790594 · EBF
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
DENTAL ALGINATE IMPRESSION MATERIAL
K790595 · ELW
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
ENAMEL BOND SYSTEM
K790596 · EBC
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
BL BILIRUBINOMETER
K790608 · CIG
Advanced Instruments, Inc.
Chemistry · 78d
Cleared Jun 15, 1979
OSMOMETER MODEL 3W11
K790611 · JJM
Advanced Instruments, Inc.
Chemistry · 78d
Cleared Jun 15, 1979
NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER
K790653 · CGZ
Nova Corp.
Chemistry · 71d