FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125353–125376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1990
NORTECH MODEL 86901000 ELECTRODE
K903427 · GXY
Andover Medical, Inc.
Neurology · 17d
Cleared Aug 17, 1990
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
K903438 · BTM
Puritan Bennett Corp.
Anesthesiology · 17d
Cleared Aug 17, 1990
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
K903443 · BTM
Puritan Bennett Corp.
Anesthesiology · 17d
Cleared Aug 17, 1990
SURGEON'S (SURGICAL) GLOVES
K903534 · KGO
Straitscom
General Hospital · 11d
Cleared Aug 17, 1990
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
K903570 · BTM
Puritan Bennett Corp.
Anesthesiology · 10d
Cleared Aug 17, 1990
PHARMACIA DELFIA SYSTEM B2-MICRO
K903578 · JZG
Pharmacia, Inc.
Immunology · 9d
Cleared Aug 17, 1990
POWDER FREE, NON-STERILE EXAMINATION GLOVES
K903607 · LYY
Tillotson Rubber Co., Inc.
General Hospital · 10d
Cleared Aug 17, 1990
INFANT MANUAL RESUSCITATOR (PMR 2)
K903631 · BTM
Puritan Bennett Corp.
Anesthesiology · 7d
Cleared Aug 15, 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · FOZ
Abbott Laboratories
General Hospital · 224d
Cleared Aug 15, 1990
ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.
K900994 · DTL
Dlp, Inc.
Cardiovascular · 166d
Cleared Aug 15, 1990
ORTHOSORB(R) ABSORBABLE PIN
K901456 · OVZ
Johnson & Johnson International
Orthopedic · 141d
Cleared Aug 15, 1990
ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A
K901725 · ITX
Kretztechnik AG
Radiology · 121d
Cleared Aug 15, 1990
SUCTION ORA-SWAB(R) BRUSH KIT
K901806 · EIA
Sage Products, Inc.
Dental · 117d
Cleared Aug 15, 1990
O. B. PACK I
K902271 · HHD
Customed, Inc.
Obstetrics & Gynecology · 86d
Cleared Aug 15, 1990
O. B. PACK II
K902272 · HHD
Customed, Inc.
Obstetrics & Gynecology · 86d
Cleared Aug 15, 1990
SCD THERAPEUTIC STOCKING SYSTEM
K902497 · DWL
Kendall Healthcare Products Co....
General Hospital · 71d
Cleared Aug 15, 1990
DEGUFILL (TM) BOND
K902744 · KLE
Degussa AG
Dental · 54d
Cleared Aug 14, 1990
AHRS EPILATOR 629
K892514 · KCX
American Hair Removal System Co.
General & Plastic Surgery · 490d
Cleared Aug 14, 1990
ULTRA II PORCELAIN POLISHING PASTE
K896071 · EJR
Shofu Dental Corp.
Dental · 299d
Cleared Aug 14, 1990
TYPE 9293 INTERFACE PULSEOX
K896738 · DQA
S & W Medico Teknik
Anesthesiology · 257d
Cleared Aug 14, 1990
ITC ANGIOGRAPHIC CATHETER
K900757 · DQA
Interventional Therapeutics Corp.
Anesthesiology · 179d
Cleared Aug 14, 1990
PERFUSION MONITOR
K900860 · DTY
Cardio Metrics, Inc.
Cardiovascular · 172d
Cleared Aug 14, 1990
INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE
K900998 · DQY
Intec Medical, Inc.
Cardiovascular · 166d
Cleared Aug 14, 1990
VISIONER 21-A
K901037 · EKS
J. Morita USA, Inc.
Dental · 161d