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
144865–144888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1986
NEG COMBO BREAKPOINT PANEL POS COMBO
K854278 · JWX
American Micro Scan
Microbiology · 131d
Cleared Mar 04, 1986
RIGIDENT CREAM
K854430 · KOT
Armkel, LLC
Dental · 119d
Cleared Mar 04, 1986
STICKY WAX
K854527 · EGD
The Hygenic Corp.
Dental · 111d
Cleared Mar 04, 1986
PREMIUM FLEXI-TOUGH
K854530 · EGD
The Hygenic Corp.
Dental · 111d
Cleared Mar 04, 1986
UROTEC CLOSED IRRIGATIION SYRINGE
K854625 · KOD
Urotec Systems Corp.
Gastroenterology & Urology · 106d
Cleared Mar 04, 1986
API 50 CHB (CULTURE MEDIA)
K854732 · JST
Dms Products, Inc.
Microbiology · 99d
Cleared Mar 04, 1986
HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER
K854795 · EIS
Fran Hazelton Co.
Dental · 92d
Cleared Mar 04, 1986
CHAMELEON BONDING KIT
K854803 · EBF
Pentron Corp.
Dental · 92d
Cleared Mar 04, 1986
DAHLBERG MODEL KC IN-THE-EAR HEARING AID
K854834 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 91d
Cleared Mar 04, 1986
DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER
K854835 · EWO
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 91d
Cleared Mar 04, 1986
TRACHEOSTOMY CARE KIT
K855130 · BTO
Dynarex Corp.
Anesthesiology · 71d
Cleared Mar 04, 1986
DYNA SYSTEM
K855167 · EGG
Parker Laboratories, Inc.
Dental · 68d
Cleared Mar 04, 1986
3M ARTHROSCOPIC SURGICAL SYSTEM
K855216 · HWE
3M Company
Orthopedic · 64d
Cleared Mar 04, 1986
SPIRAL-FLEX
K860105 · BTR
Sheridan Catheter Corp.
Anesthesiology · 50d
Cleared Mar 04, 1986
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
K860153 · JTN
Oxoid U.S.A., Inc.
Microbiology · 48d
Cleared Mar 04, 1986
INSTA KIT FOR GROUP A STREP ID
K860247 · GTZ
Mead Johnson & Co.
Microbiology · 39d
Cleared Mar 04, 1986
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
K860296 · FKQ
Physicians Surgeons Purchasing Group
Gastroenterology & Urology · 35d
Cleared Mar 04, 1986
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES
K860297 · FKQ
Renal Hygienics
Gastroenterology & Urology · 35d
Cleared Mar 04, 1986
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
K860336 · FKQ
Breem Laboratories
Gastroenterology & Urology · 34d
Cleared Mar 04, 1986
MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP
K860342 · JPA
Bio/Data Corp.
Hematology · 34d
Cleared Mar 04, 1986
DUAL LUMEN NEEDLE (PRODUCT CHANGE)
K860515 · LBW
Quinton, Inc.
Gastroenterology & Urology · 21d
Cleared Mar 04, 1986
ROTALEX
K860529 · LIQ
Orion Corp.
Microbiology · 21d
Cleared Mar 04, 1986
TBI NEEDLE
K860582 · GAA
Hobbs Medical, Inc.
General & Plastic Surgery · 14d
Cleared Mar 04, 1986
KULTSURE (CATALOGUE NO. M210)
K860656 · JSM
Ncs Diagnostics, Inc.
Microbiology · 11d