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
87313–87336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1998
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
K983263 · LOJ
Diagnostic Products Corp.
Immunology · 81d
Cleared Dec 07, 1998
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
K983345 · JJE
Bayer Corp.
Chemistry · 75d
Cleared Dec 07, 1998
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · HWC
Osteonics Corp.
Orthopedic · 61d
Cleared Dec 07, 1998
ANTI-TG IGG ELISA TEST SYSTEM
K983553 · JZO
Columbia Bioscience, Inc.
Immunology · 59d
Cleared Dec 07, 1998
POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE
K983721 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 46d
Cleared Dec 07, 1998
CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K983723 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 46d
Cleared Dec 07, 1998
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE
K983725 · LZA
Omnigrace , Ltd.
General Hospital · 46d
Cleared Dec 07, 1998
ABBOTT ARCHITECT FERRITIN
K983759 · DBF
Abbott Laboratories
Immunology · 42d
Cleared Dec 07, 1998
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
K983972 · MMI
Diagnostic Products Corp.
Chemistry · 28d
Cleared Dec 07, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS
K984011 · JJX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Dec 04, 1998
ELECTROSURGICAL UNIT
K981781 · GEI
Hill-Med, Inc.
General & Plastic Surgery · 198d
Cleared Dec 04, 1998
CUE AMBULATORY VOLUMETRIC INFUSION PUMP
K981816 · FRN
Becton Dickinson Curlin, LLC
General Hospital · 196d
Cleared Dec 04, 1998
HUMAN IGA SUBCLASS BNII COMBI KIT
K981912 · CFN
The Binding Site, Ltd.
Immunology · 186d
Cleared Dec 04, 1998
ULNAR HEAD IMPLANT
K982268 · KXE
Avanta Orthopaedics, Inc.
Orthopedic · 158d
Cleared Dec 04, 1998
RAPPORT V.T.D.
K982275 · LKY
Owen Mumford USA, Inc.
Gastroenterology & Urology · 158d
Cleared Dec 04, 1998
RUSCH POLYFLEX STENT KIT
K982614 · NYT
Rusch Intl.
General & Plastic Surgery · 130d
Cleared Dec 04, 1998
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
K982812 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 115d
Cleared Dec 04, 1998
PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE
K982885 · LYZ
Shanghai Poseidon Plastic Products...
General Hospital · 109d
Cleared Dec 04, 1998
ACCUTRAX, MODEL EPF840
K982995 · BZH
Korr Medical Technologies, Inc.
Anesthesiology · 99d
Cleared Dec 04, 1998
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
K983129 · KYB
Staar Surgical Co.
Ophthalmic · 87d
Cleared Dec 04, 1998
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
K983153 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 86d
Cleared Dec 04, 1998
MULTIPULSE CO2 LASER
K983215 · GEX
Aesculap-Meditec GmbH
General & Plastic Surgery · 81d
Cleared Dec 04, 1998
OSTEONICS X CEMENTED HIP STEM SERIES
K983226 · JDI
Osteonics Corp.
Orthopedic · 80d
Cleared Dec 04, 1998
BIPOLAR HF CABLE
K983236 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 80d