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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
111889–111912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1993
LATEX EXAMINATION GLOVE
K930557 · LYY
Ezmt Valve Co., Inc.
General Hospital · 232d
Cleared Sep 23, 1993
MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT
K931197 · KZF
Meddev International Corp.
General Hospital · 198d
Cleared Sep 23, 1993
DIOMED 25 25W SURGICAL DIODE LASER
K931212 · GEX
Dio-Med Corp.
General & Plastic Surgery · 197d
Cleared Sep 23, 1993
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L
K931411 · DTB
Medtronic Vascular
Cardiovascular · 188d
Cleared Sep 23, 1993
SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM
K931978 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 154d
Cleared Sep 23, 1993
DISPOSABLE INSUFFLATION TUBING
K932045 · GCJ
L.A.S.E.R., Inc.
General & Plastic Surgery · 149d
Cleared Sep 23, 1993
ELECTROSURGICAL ELECTRODE
K932102 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 143d
Cleared Sep 23, 1993
ALPHA-DENT CORE BUILDUP PASTE
K932827 · EBF
Alpha-Dent
Dental · 106d
Cleared Sep 23, 1993
A MANO TONGUE CLEANSER
K932839 · LCN
A Mano Products, Ltd.
Dental · 104d
Cleared Sep 23, 1993
SURGICAL TROCAR AND CANNULA
K932995 · GCJ
Applied Medical Resources
General & Plastic Surgery · 97d
Cleared Sep 23, 1993
ESB 2400 SEI
K933146 · FTC
Esb, Inc., Div. of Ray-O-Vac
General & Plastic Surgery · 86d
Cleared Sep 23, 1993
MODEL 6400 ABC ELECTROSURGERY GENERATOR
K933332 · GEI
William E. Mckay
General & Plastic Surgery · 77d
Cleared Sep 23, 1993
HGM SCANMAN PLUS
K933333 · GEX
Hgm, Inc.
General & Plastic Surgery · 77d
Cleared Sep 23, 1993
QB II BLUNT DISSECTOR
K933604 · FGS
Joyce M. Shotwell, M.D.
Gastroenterology & Urology · 58d
Cleared Sep 22, 1993
NORODYN 2000 ELECTROMYOGRAPH
K922838 · HCC
Noromed, Inc.
Neurology · 467d
Cleared Sep 22, 1993
BIOSCOPE
K923406 · DPS
Biotronik, GmbH & Co.
Cardiovascular · 439d
Cleared Sep 22, 1993
INTIMA POINT GUARD INTRAVASCULAR CATHETER
K923702 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 425d
Cleared Sep 22, 1993
HEMOSTASIS VALVE AND TUBING SET
K930194 · DYB
Opticon Medical, Inc.
Cardiovascular · 251d
Cleared Sep 22, 1993
ON-LINE ANALYSIS SYSTEM
K930639 · DQK
Softheart, Inc.
Cardiovascular · 225d
Cleared Sep 22, 1993
INTROPEEL
K930801 · DYB
Menlo Care, Inc.
Cardiovascular · 218d
Cleared Sep 22, 1993
INTROPEEL V
K931218 · DYB
Menlo Care, Inc.
Cardiovascular · 196d
Cleared Sep 22, 1993
GERTIE MARX NEEDLE
K931644 · BSP
Intl. Medical-Dental Products USA, Inc.
Anesthesiology · 173d
Cleared Sep 22, 1993
NOVUS MULTIWAVELENGTH
K932468 · GEX
Coherent Medical Group
General & Plastic Surgery · 121d
Cleared Sep 22, 1993
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
K933188 · JPA
Baxter Diagnostics, Inc.
Hematology · 84d