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
167209–167232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1980
HEMOGASTAT
K801148 · JRR
Therapac, Inc.
Hematology · 27d
Cleared Jun 09, 1980
TECHNICON H6000 HEMATOLOGY SYSTEM
K801155 · GKL
Technicon Instruments Corp.
Hematology · 26d
Cleared Jun 09, 1980
CENTRIFICHEM SYSTEM 400
K801167 · JQP
Union Carbide Corp.
Chemistry · 25d
Cleared Jun 09, 1980
CONPHAR DELUXE ANEROID SPHYGMOMANOMETER
K801186 · DXQ
Conphar, Inc.
Cardiovascular · 21d
Cleared Jun 09, 1980
CONPHAR CHECKMATE SPHYGMOMANOMETER
K801187 · DXN
Conphar, Inc.
Cardiovascular · 21d
Cleared Jun 09, 1980
CONPHAR DESK TOP MERCURY SPHYGMOMAN
K801188 · DXQ
Conphar, Inc.
Cardiovascular · 21d
Cleared Jun 09, 1980
DERMALEX OR NATRAWOOL SKIN PRESSURE PROT
K801195 · FMP
Stock Wild & Co.
General Hospital · 24d
Cleared Jun 09, 1980
CORTISOL RADIOIMMUNOASSAY KIT
K801203 · CGR
Technia Diagnostics , Ltd.
Chemistry · 21d
Cleared Jun 09, 1980
EMIT DISOPYRAMIDE ASSAY
K801204 · KLR
Syva Co.
Chemistry · 21d
Cleared Jun 09, 1980
EMIT DISOPYRAMIDE CONTROL
K801205 · LAS
Syva Co.
Toxicology · 21d
Cleared Jun 09, 1980
THORA-DRAIN III PLASTIC DRAINAGE SYSTEM
K801221 · KDQ
Chesebrough-Pond'S U.S.A. Co.
General Hospital · 18d
Cleared Jun 09, 1980
PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A
K801223 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 17d
Cleared Jun 09, 1980
REIGNING DENTURE MADE OF POLYCARB. RESIN
K801234 · EBI
Oki Shiks USA , Ltd.
Dental · 13d
Cleared Jun 09, 1980
REIGNING CROWN-BRIDGE/POLYCARB. RESIN
K801237 · EBF
Oki Shiks USA , Ltd.
Dental · 13d
Cleared Jun 09, 1980
PENLON I.D.P. PRESSSURE FAILURE ALARM
K801254 · CAP
Penlon, Inc.
Anesthesiology · 12d
Cleared Jun 09, 1980
NEEDLE COUNTER-SURE COUNT/100 COUNT
K801259 · MMK
Kleen Test Products
General Hospital · 12d
Cleared Jun 09, 1980
DISPOSABLE COUPLING ADAPTOR
K801261 · BYX
Intec Medical, Inc.
Anesthesiology · 12d
Cleared Jun 09, 1980
MODEL 4900 OFF-LINE PREPARATION SYSTEM
K801271 · JQW
Pm America, Inc.
Chemistry · 12d
Cleared Jun 09, 1980
S.S. WHITE-PENNWALT PRELUDE PIT SEALANT
K801274 · EBC
Pennwalt Corp.
Dental · 11d
Cleared Jun 09, 1980
COMPRESSION MOLDING OF UHMWPE
K801313
Howmedica Corp.
Orthopedic · 6d
Cleared Jun 09, 1980
THE EXTRACTOR I TM
K801327 · HWB
The Anspach Effort, Inc.
Orthopedic · 6d
Cleared Jun 09, 1980
THE EQUALIZER
K801328 · MDM
The Anspach Effort, Inc.
General & Plastic Surgery · 6d
Cleared Jun 09, 1980
ANSPACH INSTRUMENT CADDY
K801329 · HSZ
The Anspach Effort, Inc.
Orthopedic · 6d
Cleared Jun 04, 1980
LIFELINE TLE (TRAEBECULAR LODGING ELEC
K792300 · DTB
Intermedics, Inc.
Cardiovascular · 202d