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
152017–152040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1984
POLYURETHANE THERMAL DILUTION CATHET
K841876 · DYG
Waters Instruments, Inc.
Cardiovascular · 67d
Cleared Jul 13, 1984
SHEATH REMOVER
K841878 · LJS
Datascope Corp.
General Hospital · 67d
Cleared Jul 13, 1984
KERR SEALAPEX ROOT CANAL SEALER
K841910 · EJK
Sybron Corp.
Dental · 65d
Cleared Jul 13, 1984
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232
K841922 · FRN
American Edwards Laboratories
General Hospital · 64d
Cleared Jul 13, 1984
PERCUTANEOUS CATHETER INTRODUCER SET
K842004 · DYB
Aries Medical, Inc.
Cardiovascular · 58d
Cleared Jul 13, 1984
AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
K842113 · DRE
Mallinckrodt Critical Care
Cardiovascular · 116d
Cleared Jul 13, 1984
RAAF DUAL LUMEN CATHETER
K842176 · DQY
Quinton, Inc.
Cardiovascular · 35d
Cleared Jul 13, 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 39d
Cleared Jul 13, 1984
DISPOSABLE PILLOW
K842336 · KME
Monterey Mills, Inc.
General Hospital · 30d
Cleared Jul 13, 1984
ERIKA NEGATIVE PRESS. ARTERIAL BLOOD
K842436 · KOC
Erika, Inc.
Gastroenterology & Urology · 23d
Cleared Jul 13, 1984
PENTAD VOCALIZER
K842535 · ILQ
Pentad Corp.
Physical Medicine · 15d
Cleared Jul 12, 1984
GENERATED RETINAL REFLEX IMAGERY SYS
K840840 · HKM
Electro Optical Instruments
Ophthalmic · 139d
Cleared Jul 12, 1984
LAKEVILLE BODY VENTILATOR
K840885 · BYT
Edwards Ventilator Co.
Anesthesiology · 136d
Cleared Jul 12, 1984
HAEMATURIA CATHETERS
K841511 · KOD
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 92d
Cleared Jul 12, 1984
LIFESCAN EEG MONITOR
K841790 · OLT
Neurometrics
Neurology · 73d
Cleared Jul 12, 1984
NATURA-DENT VACUUM-FIRED PORCELAIN TEETH
K841826 · ELL
Parexel Intl. Corp.
Dental · 71d
Cleared Jul 12, 1984
JOHNSON & JOHNSON FLAVORED ETCHING GEL
K842078 · KLE
Johnson & Johnson Professionals, Inc.
Dental · 50d
Cleared Jul 12, 1984
BISFIL-I LIGHT CURABLE POSTERIOR COMPO
K842087 · EBF
Bisco, Inc.
Dental · 49d
Cleared Jul 12, 1984
SLIDE PREGNANCY TEST
K842110 · JHJ
Immunostics Co., Inc.
Chemistry · 44d
Cleared Jul 12, 1984
WAKO GLUCOSE C
K842221 · CGA
Wako Pure Chemical Industries, Ltd.
Chemistry · 37d
Cleared Jul 11, 1984
RELIABLE
K834479 · LRB
Reliable Hearing Aide
Ear, Nose, Throat · 204d
Cleared Jul 11, 1984
BETA STICK, PREGNANCY TEST
K841415 · LCX
Quidel Corp.
Chemistry · 97d
Cleared Jul 11, 1984
DRILL GUIDE
K841619 · FZX
Plastafil, Inc.
General & Plastic Surgery · 83d
Cleared Jul 11, 1984
SOFT-TISSUE INSTRUMENT
K841622 · HWQ
Plastafil, Inc.
Orthopedic · 83d