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
141889–141912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1986
SCHEIN BLEACHING UNIT
K862385 · EEG
Henry Schein, Inc.
Dental · 128d
Cleared Oct 30, 1986
WHITE-SIPOSS TUBE, CAT NO WS-1
K862950 · BTR
American Omni Medical, Inc.
Anesthesiology · 86d
Cleared Oct 30, 1986
OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
K863207 · BSZ
Ohmeda Medical
Anesthesiology · 72d
Cleared Oct 30, 1986
SHINER STRESS DIRECTING ATTACHMENT
K863243 · EGG
Js & R - R & D Co.
Dental · 69d
Cleared Oct 30, 1986
GUTTA PERCHA
K863411 · EKM
Endodent, Inc.
Dental · 57d
Cleared Oct 30, 1986
GUTTA PERCHA POINTS
K863638 · EKM
Endodent, Inc.
Dental · 43d
Cleared Oct 30, 1986
FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000
K863753 · KGX
Foundations Plus, Inc.
General & Plastic Surgery · 35d
Cleared Oct 30, 1986
DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY
K863766 · EAX
The Medical Group, Inc.
Dental · 35d
Cleared Oct 30, 1986
GLASS MOUTH MIRRORS, REUSABLE
K863767 · EAX
The Medical Group, Inc.
Dental · 35d
Cleared Oct 30, 1986
EVACUATOR TIPS
K863769 · EHZ
The Medical Group, Inc.
Dental · 35d
Cleared Oct 30, 1986
COLTENE JET-MIXER
K863998 · EID
Coltene, Inc.
Dental · 16d
Cleared Oct 30, 1986
SLOTTED PUNCH
K864017
Med-Tool, Inc.
General & Plastic Surgery · 15d
Cleared Oct 30, 1986
HACKSAW
K864018
Med-Tool, Inc.
General & Plastic Surgery · 15d
Cleared Oct 30, 1986
NEEDLE NOSE PLIERS
K864019 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 15d
Cleared Oct 30, 1986
ICE PICK
K864020
Med-Tool, Inc.
General & Plastic Surgery · 15d
Cleared Oct 30, 1986
NONCONDUCTIVE SHOE COVER
K864026 · FXP
Kimberly-Clark Corp.
General Hospital · 15d
Cleared Oct 30, 1986
LATEX SURGICAL GLOVES
K864064 · KGO
Futuremed Div. of Future Impex Corp.
General Hospital · 10d
Cleared Oct 30, 1986
COOK (R) VEIN GRAFT RING MARKERS
K864101 · KPK
Cook, Inc.
Cardiovascular · 9d
Cleared Oct 30, 1986
STERILE FIELD #605 FENESTRATED STERILE FIELD #606
K864111 · KKX
Graham Medical Products
General Hospital · 9d
Cleared Oct 29, 1986
THE WELLCOME ROTAVIRUS LATEX TEST ZL40
K861634 · LIQ
Wellcome Diagnostics
Microbiology · 183d
Cleared Oct 29, 1986
IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
K861882 · MSJ
Orion Corp.
Immunology · 167d
Cleared Oct 29, 1986
IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1
K861883 · MSJ
Orion Corp.
Immunology · 167d
Cleared Oct 29, 1986
MEVATRON KD-2
K862339 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 131d
Cleared Oct 29, 1986
STARCHILD SLEEPDRY
K862757 · KPN
Starchild, Inc.
Gastroenterology & Urology · 99d