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
164641–164664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1981
REGULATOR, OXYGEN MECHANICAL
K803207 · CAN
Timeter Instrument Corp.
Anesthesiology · 28d
Cleared Jan 15, 1981
ACMI BIPOLAR HEMOSTATIC ELECTRODE
K803214 · FEH
American Cystocope Makers, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 15, 1981
CORDIS HAKIM ASCITES VALVE SYSTEM
K803258 · KPM
Cordis Corp.
Gastroenterology & Urology · 23d
Cleared Jan 15, 1981
T3 RIABEAD DIAGNOSTIC KIT
K803261 · CDP
Abbott Laboratories
Chemistry · 22d
Cleared Jan 15, 1981
CAPSULE DENTAL AMALGAM
K803269
Dentsply Intl.
Dental · 17d
Cleared Jan 15, 1981
COLD/HOT PACK
K803299 · IME
W.G. Whitney Corp.
Physical Medicine · 16d
Cleared Jan 15, 1981
PENTAX UPPER G.I. FIBERSCOPE, #FG-34
K810007 · GDB
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 10d
Cleared Jan 15, 1981
FOOT BATHS & HAND MASSAGERS
K810034 · ILJ
Associated Mills, Inc.
Physical Medicine · 9d
Cleared Jan 14, 1981
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
K802975 · EBF
Dentsply Intl.
Dental · 54d
Cleared Jan 14, 1981
ELIPAR LIGHT SOURCE
K803209 · EBZ
Espe-Premier Sales Co.
Dental · 27d
Cleared Jan 14, 1981
VISIO-DISPERS
K803227 · EBF
Espe-Premier Sales Co.
Dental · 26d
Cleared Jan 14, 1981
CERAMCO PORCELAIN
K803310 · EIH
Johnson & Johnson Professionals, Inc.
Dental · 12d
Cleared Jan 14, 1981
ORTHODONTIC BRACKET
K803316 · EJF
Orec Corp.
Dental · 15d
Cleared Jan 14, 1981
POST-AURICULAR HEARING AID (#PE830)
K810030 · ESD
Hc Electronics
Ear, Nose, Throat · 8d
Cleared Jan 13, 1981
DATASCOPE/AVCO CONNECTOR
K801601 · DSP
Datascope Corp.
Cardiovascular · 183d
Cleared Jan 13, 1981
PERCOR DATASCOPE INTRA-AORTIC BALLOON
K802167 · DSP
Datascope Corp.
Cardiovascular · 127d
Cleared Jan 13, 1981
TECNOL O.R. TOURNIQUET COVER
K802850 · EYR
Tecnol New Jersey Wound Care, Inc.
General & Plastic Surgery · 62d
Cleared Jan 13, 1981
FOGARTY BALLON ANGIOPLASTY CATHETERS
K803057 · LIT
American Edwards Laboratories
Cardiovascular · 42d
Cleared Jan 13, 1981
SUN TANNING DEVICES
K803061 · LEJ
Mutzhas Corp.
Radiology · 40d
Cleared Jan 13, 1981
NARCO TELECARE TRANSDUCER DOME #700-4000
K803096 · DRS
Narco Scientific
Cardiovascular · 36d
Cleared Jan 13, 1981
CRT DISPLAY #1310B
K803123 · DXJ
Hewlett-Packard Co.
Cardiovascular · 33d
Cleared Jan 13, 1981
CONPHAR VELCRO TOUNIGUER
K803142 · GAX
Conphar, Inc.
General & Plastic Surgery · 32d
Cleared Jan 13, 1981
ADVANCEMED CCU DOCUMENTOR
K803222 · DSH
American Edwards Laboratories
Cardiovascular · 25d
Cleared Jan 13, 1981
ADVANCMED ELIMINATOR
K803223 · DRT
American Edwards Laboratories
Cardiovascular · 25d