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
117793–117816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1992
DENTACOLOR(R) CRE-ACTIVE
K914456 · EBF
Heraeus Kulzer, Inc.
Dental · 156d
Cleared Mar 11, 1992
IL TEST(TM) UREA NITROGEN
K914877 · CDQ
Instrumentation Laboratory CO
Chemistry · 134d
Cleared Mar 11, 1992
DISPOSABLE CAUTERY ABRASIVE PAD
K915064 · KDC
American Medical Mfg., Inc.
General & Plastic Surgery · 124d
Cleared Mar 11, 1992
DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS
K915067 · MMK
American Medical Corp.
General Hospital · 124d
Cleared Mar 11, 1992
NEUROFAX EEG 5532
K915096 · GWQ
Nihon Kohden America, Inc.
Neurology · 120d
Cleared Mar 11, 1992
PORTABLE OXYGEN GENERATOR
K915381 · CAW
Aequitron Medical, Inc.
Anesthesiology · 103d
Cleared Mar 11, 1992
BIPOLAR ENDOSTASIS PROBE, BEST (TM)
K915408 · KNS
Medical Devices, Inc.
Gastroenterology & Urology · 100d
Cleared Mar 11, 1992
ZEISS MULTIYAG LASER
K915561 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 90d
Cleared Mar 11, 1992
IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE
K915577 · CAR
Impra, Inc.
General Hospital · 89d
Cleared Mar 11, 1992
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
K915596 · KWT
Biomet, Inc.
Orthopedic · 89d
Cleared Mar 11, 1992
AMERLITE PROCESSING CENTER
K915680 · JJQ
Eastman Kodak Company
Chemistry · 83d
Cleared Mar 11, 1992
STC DIAGNOSTICS BENZOYLECGONINE EIA
K915785 · JXO
Solarcare Technologies Corp,Inc.
Chemistry · 78d
Cleared Mar 11, 1992
ACKRAD ERCP CONTRAST DELIVERY SET
K915813 · FGE
Ackrad Laboratories
Gastroenterology & Urology · 72d
Cleared Mar 11, 1992
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE
K915825 · GKF
Fisher Scientific Co., LLC
Hematology · 72d
Cleared Mar 11, 1992
IL TEST IMMUNOGLOBULIN M (IGM)
K920008 · CGM
Instrumentation Laboratory CO
Immunology · 69d
Cleared Mar 11, 1992
OSTEO COMPRESSION HIP SCREW
K920037 · HRC
Osteo AG
Ophthalmic · 65d
Cleared Mar 11, 1992
ULTRASAFE
K920059 · LYY
Ultrawin Sdn Bhd
General Hospital · 65d
Cleared Mar 11, 1992
LH GEN III SELF-TEST/CONCEIVE
K920160 · CEP
Quidel Corp.
Chemistry · 57d
Cleared Mar 11, 1992
SPECTACLE FRAME
K920170 · HQZ
Sciara Intl., Inc.
Ophthalmic · 58d
Cleared Mar 11, 1992
SYN ELISA MICRO ALBUMIN
K920216 · JIR
Elias U.S.A., Inc.
Chemistry · 55d
Cleared Mar 11, 1992
MILES LIPASE SERA-PAK METHOD
K920337 · CHI
Heraeus Kulzer, Inc.
Chemistry · 47d
Cleared Mar 11, 1992
ISOTYPES HUMAN IGG SUBCLASS EIA KIT
K920370 · CGM
Isotypes, Inc.
Immunology · 43d
Cleared Mar 11, 1992
IMMULITE HLH
K920411 · CEP
Cirrus Diagnostics, Inc.
Chemistry · 40d
Cleared Mar 11, 1992
IL TEST DAT CAL/CONTROL SET D/E
K920419 · DLG
Instrumentation Laboratory CO
Toxicology · 40d