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
132817–132840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1989
MAXIBOND
K884575 · DYH
Ortho Source
Dental · 63d
Cleared Jan 03, 1989
OPHTHASCAN MINI-B
K884595 · IYO
Biophysic Medical, Inc.
Radiology · 61d
Cleared Jan 03, 1989
UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT
K884681 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 56d
Cleared Jan 03, 1989
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
K884736 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Jan 03, 1989
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
K884909 · CGA
American Research Products Co.
Chemistry · 41d
Cleared Jan 03, 1989
ALANINE AMINOTRANSFERASE
K884936 · CKA
Catachem, Inc.
Chemistry · 39d
Cleared Dec 30, 1988
TRANSFER CONTAINER HUMIDIFIER
K881648 · CAF
Newport Biosystems, Inc.
Anesthesiology · 259d
Cleared Dec 30, 1988
INFUSION PUMP
K882830 · LZF
Pemlab Corp.
General Hospital · 175d
Cleared Dec 30, 1988
DADE FACTOR VIII CHROMOGENIC ASSAY
K884544 · GGP
Baxter Healthcare Corp
Hematology · 60d
Cleared Dec 30, 1988
DADE FACTOR IX CHROMOGENIC ASSAY
K884551 · GGP
Baxter Healthcare Corp
Hematology · 60d
Cleared Dec 30, 1988
EXEL 905 SERIES CT SCANNER
K884667 · JAK
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
EXEL 1002 CT SCANNER
K884668 · JAK
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
EXEL 2002 & 2002FS CT SCANNER
K884669 · JAK
Elscint, Inc.
Radiology · 52d
Cleared Dec 30, 1988
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE
K885076 · JPA
Organon Teknika Corp.
Hematology · 22d
Cleared Dec 30, 1988
DIOPTICS EYESHIELDS
K885163 · HOY
Dioptics
Ophthalmic · 17d
Cleared Dec 29, 1988
NEURAL MAGNETIC STIMULATOR, THE D190
K883340 · GWF
Tracor Northern, Inc.
Neurology · 142d
Cleared Dec 29, 1988
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER
K884035 · JJE
Sclavo, Inc.
Chemistry · 97d
Cleared Dec 29, 1988
MODIFIED CHICK AMBULATORY HALO
K884242 · JEC
Chick Medical Products
Orthopedic · 79d
Cleared Dec 29, 1988
ROGOZINSKI SPINAL SYSTEM
K884263 · KWP
Richards Medical Co., Inc.
Orthopedic · 79d
Cleared Dec 29, 1988
CLENSATRON AUTOMATIC CONTACT LENS CLEANER
K884414 · LYL
Questech Intl., Inc.
Ophthalmic · 70d
Cleared Dec 29, 1988
AE-800PA EEG MODULE
K884537 · GWQ
Nihon Kohden America, Inc.
Neurology · 62d
Cleared Dec 29, 1988
VIRGO(R) MICROWELL ALT ASSAY
K884784 · CKD
Electro-Nucleonics, Inc.
Chemistry · 44d
Cleared Dec 29, 1988
MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS
K884888 · JDI
Protek, Inc.
Orthopedic · 37d
Cleared Dec 29, 1988
VISUAL BLOOD GLUCOSE TEST SYSTEM
K884993 · CGA
Diagnostic Systems
Chemistry · 28d