FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132793–132816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1989
POLYGLUCOSE POWDER
K884422 · FRO
Anthony N Silvetti, M.D., S.C.
General & Plastic Surgery · 123d
Cleared Feb 22, 1989
DAIG COLLAPSIBLE STERILE SLEEVE
K884478 · DQR
Daig Corp.
Cardiovascular · 120d
Cleared Feb 22, 1989
DAIG OBTURATOR, CATHETER INTRODUCER
K884494 · DYB
Daig Corp.
Cardiovascular · 120d
Cleared Feb 22, 1989
ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS
K884811 · DTB
Telectronics and Control Pacing Systems
Cardiovascular · 97d
Cleared Feb 22, 1989
RESOUND HES, DIGITALLY PROGR., ITE HEARING AID
K884871 · ESD
Resound Corp.
Ear, Nose, Throat · 93d
Cleared Feb 22, 1989
SOLARETTES
K884878 · HQY
Dioptics
Ophthalmic · 93d
Cleared Feb 22, 1989
INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM
K885154 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 69d
Cleared Feb 22, 1989
CURITY CONTINUOUS SPINAL ANESTHESIA TRAY
K885238 · CAZ
The Kendal Co.
Anesthesiology · 63d
Cleared Feb 22, 1989
COULTER FLOW RETICULOCYTE REAGENT
K885332 · GKL
Coulter Electronics, Inc.
Hematology · 56d
Cleared Feb 22, 1989
MULTISKOP
K890352 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Feb 22, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGG
K890416 · DEW
Atlantic Antibodies
Immunology · 29d
Cleared Feb 22, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR HPT
K890562 · DAD
Atlantic Antibodies
Immunology · 29d
Cleared Feb 22, 1989
VITALON CHAIR MASSAGER MODEL V-CHR2
K890643 · ISA
Nexus Co. , Ltd. C/O Yama Trans Co. ,...
Physical Medicine · 14d
Cleared Feb 17, 1989
PHADEBACT SHIGELLA TEST
K880752 · GNB
Pharmacia, Inc.
Microbiology · 359d
Cleared Feb 17, 1989
OXYGENATION CATHETER
K881881 · BTM
Ventech Healthcare Corp., Inc.
Anesthesiology · 289d
Cleared Feb 17, 1989
NITRONOX(R), FIRST RESPONSE NITRONOX(TM)
K883833 · BZR
Matrix Medica, Inc.
Anesthesiology · 161d
Cleared Feb 17, 1989
AXIOM ATRAUM WOUND DRAINS
K883887 · GBS
Axiom, Inc.
General & Plastic Surgery · 157d
Cleared Feb 17, 1989
DRUG STANDARD SET
K884177 · DKB
Gelman Sciences, Inc.
Toxicology · 136d
Cleared Feb 17, 1989
DRUG CONTROL SET
K884178 · DIF
Gelman Sciences, Inc.
Toxicology · 136d
Cleared Feb 17, 1989
STAAR PHACO XL SMALL INCISION SYSTEM
K884241 · HQC
Staar Surgical Co.
Ophthalmic · 129d
Cleared Feb 17, 1989
QUIDEL FOOD ALLERGY SCREEN
K884501 · DHB
Quidel Corp.
Immunology · 114d
Cleared Feb 17, 1989
MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)
K884782 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 94d
Cleared Feb 17, 1989
O'NEIL URINARY CATHETER INTRODUCER
K884819 · KNY
Medical Marketing Group
Gastroenterology & Urology · 92d
Cleared Feb 17, 1989
KINEMAX TIBIAL WEDGE
K884837 · HRY
Howmedica Corp.
Orthopedic · 91d