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
123505–123528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1990
ANGIOTEC IMAGE MANAGEMENT SYSTEM
K903806 · LMB
Andros Analyzers, Inc.
Radiology · 95d
Cleared Nov 23, 1990
NEONATAL METASCOPE
K903959 · BZK
Cybermedic, Inc.
Anesthesiology · 87d
Cleared Nov 23, 1990
HTR POLYMER, HTR-MX
K904111 · KKY
United States Surgical, A Division of...
General & Plastic Surgery · 78d
Cleared Nov 23, 1990
DUAL LUMEN NEEDLES
K904433 · LBW
Akcess Medical Products, Inc.
Gastroenterology & Urology · 56d
Cleared Nov 23, 1990
LABELLING MODIFICATION TO MAXX PLUS
K904453 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 57d
Cleared Nov 23, 1990
HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE
K904526 · LYY
Malaytex USA, Inc.
General Hospital · 53d
Cleared Nov 21, 1990
BIOCLUSIVE(R) ABSORBENT DRESSING
K896828 · KOZ
Johnson & Johnson International
General & Plastic Surgery · 352d
Cleared Nov 21, 1990
PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
K900295 · KDJ
Microwave Medical Systems, Inc.
Gastroenterology & Urology · 303d
Cleared Nov 21, 1990
FOLEY CATHETER
K902710 · EZL
Societa Gruppi Elastomeri S.A.
Gastroenterology & Urology · 154d
Cleared Nov 21, 1990
VERIFUSE AMBULATORY PUMP
K902891 · FRN
Block Medical, Inc.
General Hospital · 142d
Cleared Nov 21, 1990
ARGON BEAM LAPAROSCOPIC ELECTRODE
K902996 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 135d
Cleared Nov 21, 1990
NIDEK US-2000
K903326 · IYO
Nidek, Inc.
Radiology · 119d
Cleared Nov 21, 1990
SYRINGE INFUSION PUMP
K903343 · FRN
Baxter Healthcare Corp
General Hospital · 119d
Cleared Nov 21, 1990
ALRGN SET
K903637 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 100d
Cleared Nov 21, 1990
DERMASORB WOUND CONTACT LAYER DRESSING
K903645 · KOZ
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 99d
Cleared Nov 21, 1990
USCI(R) SILK (TM) GUIDE WIRE
K903923 · DQX
C.R. Bard, Inc.
Cardiovascular · 89d
Cleared Nov 21, 1990
MODEL MC 1100 SURGICAL YAG LASER
K903943 · GEX
Klinger Micro-Controle Group
General & Plastic Surgery · 86d
Cleared Nov 21, 1990
SURGICAL ASPIRATOR KIT
K904010 · LFL
Surgeon Surgical Instrumentation, Inc.
General & Plastic Surgery · 84d
Cleared Nov 21, 1990
UC IMU B
K904137 · DFC
Eucardio Laboratory, Inc.
Immunology · 76d
Cleared Nov 21, 1990
PREVEN-A-STIK
K904148 · MMK
Preven-A-Stik, Inc.
General Hospital · 75d
Cleared Nov 21, 1990
MEDILAS 4060N FIBERTOM(R) SURGICAL LASER
K904155 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 75d
Cleared Nov 21, 1990
ACCUPLACE (TM)
K904172 · GDF
Dlp, Inc.
General & Plastic Surgery · 71d
Cleared Nov 21, 1990
SITE DIAPHRAGM CASSETTE
K904186 · KYG
Site Microsurgical Systems, Inc.
Ophthalmic · 70d
Cleared Nov 21, 1990
DISPOSABLE BEARD COVER
K904276 · FXY
Anago, Inc.
General Hospital · 63d