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
124105–124128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 21, 1990
NONPRESCRIPTION SUNGLASSES
K904281 · HQY
Jennie G. Sales Co., Inc.
Ophthalmic · 65d
Cleared Nov 21, 1990
CODMAN COLLINS RADIOPARENT STERNAL BLADES
K904352 · DWH
Codman & Shurtleff, Inc.
General & Plastic Surgery · 58d
Cleared Nov 21, 1990
MODEL 6/01 UV-B FIXTURE
K904425 · FTC
Strato-Ray Co.
General & Plastic Surgery · 55d
Cleared Nov 21, 1990
MILENIA (TM) METHAMPHETAMINE
K904451 · DKZ
Diagnostic Products Corp.
Chemistry · 54d
Cleared Nov 21, 1990
ELASTOPLAST
K904500 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 50d
Cleared Nov 21, 1990
EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)
K904685 · FPA
Exel Intl.
General Hospital · 48d
Cleared Nov 21, 1990
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · KOD
Baxter Healthcare Corp
Gastroenterology & Urology · 35d
Cleared Nov 21, 1990
PATIENT EXAMINATION GLOVE/HYPOALLERGENIC
K905109 · FMC
Tactyl Technologies, Inc.
General Hospital · 8d
Cleared Nov 20, 1990
SYRINGE NEEDLE INTRODUCER
K901803 · KZH
Glaxo, Inc.
General Hospital · 215d
Cleared Nov 20, 1990
MEDICAL PROCEDURE TRAY
K902410 · LDQ
Sorex Medical
General & Plastic Surgery · 173d