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
125473–125496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3
K902938 · LLL
General Biometrics, Inc.
Immunology · 37d
Cleared Aug 09, 1990
FIXATION STAPLE
K903022 · JDR
Onyx Medical Corp.
Orthopedic · 30d
Cleared Aug 09, 1990
ROCHE ISOMUNE- CK
K903025 · JHS
Roche Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Aug 09, 1990
IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4
K903047 · LLL
General Biometrics, Inc.
Immunology · 29d
Cleared Aug 09, 1990
ARGENCO 18
K903059 · EJT
Argen Precious Metals, Inc.
Dental · 31d
Cleared Aug 09, 1990
SEROCARD HSV IGG ANTIBODY TEST KIT
K903070 · LGC
Disease Detection International, Inc.
Microbiology · 28d
Cleared Aug 09, 1990
INNOFLUOR (TM) AMIKACIN REAGENT SET
K903100 · KLQ
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Aug 09, 1990
SYNERMED CHLORIDE REAGENT KIT
K903103 · CHG
Synermed, Inc.
Chemistry · 27d
Cleared Aug 09, 1990
ARGENCO 1
K903119 · EJT
Argen Precious Metals, Inc.
Dental · 24d
Cleared Aug 09, 1990
ARGENCO 23
K903120 · EJT
Argen Precious Metals, Inc.
Dental · 24d
Cleared Aug 09, 1990
CHEM-CHEX-ALT
K903147 · JJX
Streck Laboratories, Inc.
Chemistry · 22d
Cleared Aug 09, 1990
EMIT ETHYL ALCOHOL ASSAY
K903153 · DIC
Syva Co.
Toxicology · 22d
Cleared Aug 09, 1990
EURAMARK 610 PHOTOMETER
K903164 · JJQ
Euro-American Marketing Group, Inc.
Chemistry · 22d
Cleared Aug 09, 1990
BROAD SELF-COMPRESSING PLATE
K903252 · HRS
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
CANCELLOUS SCREW
K903253 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
U.S. TYPE CRUCIATE SLOT BONE SCREW
K903254 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
CORTICAL BONE SCREW (EUROPEAN STYLE)
K903255 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
HAGIE PIN
K903258 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
KNOWLES PIN
K903259 · HWC
Onyx Medical Corp.
Orthopedic · 16d
Cleared Aug 09, 1990
MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE
K903419 · GDH
United States Surgical, A Division of...
General & Plastic Surgery · 9d
Cleared Aug 08, 1990
QSI 9000
K894560 · GWF
Quantified Signal Imaging, Inc.
Neurology · 384d
Cleared Aug 08, 1990
CADD-PCA AMBULATORY INFUSION PUMPS
K895644 · FRN
Pharmacia Deltec, Inc.
General Hospital · 322d
Cleared Aug 08, 1990
BIOTRONIK'S PS-ENDOCARDIAL LEADS
K896824 · DTB
Biotronik, GmbH & Co.
Cardiovascular · 247d
Cleared Aug 08, 1990
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
K900645 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 180d