FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
166369–166392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 04, 1980
LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL
K792301 · DTB
Intermedics, Inc.
Cardiovascular · 202d
Cleared Jun 04, 1980
SUN SCENE TAN BOOTH
K800592
Sun Scene International, Inc.
Radiology · 79d
Cleared Jun 04, 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725 · GGW
Abbott Laboratories
Hematology · 64d
Cleared Jun 04, 1980
SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1
K800744 · LEJ
Sun Ind., Inc.
Radiology · 62d
Cleared Jun 04, 1980
OMNITON MT80-A BODY HEARING AID
K800779 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 57d
Cleared Jun 04, 1980
ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.
K800838 · DXY
Arco Medical Products Co.
Cardiovascular · 50d