Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
76297–76320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2002
MODIFICATION TO SPARC SLING SYSTEM
K021263 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared May 15, 2002
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · BTA
Medela AG
General & Plastic Surgery · 15d
Cleared May 15, 2002
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
K021422 · MHX
Philips Medical Systems
Cardiovascular · 12d
Cleared May 14, 2002
REPROCESSED COMPRESSION LIMB SLEEVES
K012658 · JOW
Surgical Instruments Service and...
Cardiovascular · 274d
Cleared May 14, 2002
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
K013587 · KKO
Babies Best, Inc.
Dental · 196d
Cleared May 14, 2002
NYCOCARD CRP
K013787 · DCK
Primus Corp.
Chemistry · 181d
Cleared May 14, 2002
MICROJET CRONO PAR AND CRONO APO-GO
K013840 · FRN
Cane S.R.L.
General Hospital · 176d
Cleared May 14, 2002
LATEX SURGEONS GLOVE (POWDERED)
K014278 · KGO
Brightway Gloves Pvt. , Ltd.
General Hospital · 138d
Cleared May 14, 2002
I-STAT PROTHROMBIN TIME TEST
K020355 · GJS
I-Stat Corporation
Hematology · 99d
Cleared May 14, 2002
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
K020489 · JPD
Tosoh Medics, Inc.
Hematology · 90d
Cleared May 14, 2002
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
K020618 · GLK
Aalto Scientific, Ltd.
Hematology · 78d
Cleared May 14, 2002
STERISHARP 3-GALLON RSDC, MODEL RSDC3G
K020664 · MMK
Sterilogic Waste Systems, Inc.
General Hospital · 74d
Cleared May 14, 2002
MS-30 LATERAL FEMORAL STEM
K020713 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 70d
Cleared May 14, 2002
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
K020816 · JIY
Diagnostic Chemicals , Ltd.
Chemistry · 62d
Cleared May 14, 2002
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
K020823 · DFZ
Sanquin Blood Supply Foundation
Immunology · 61d
Cleared May 14, 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
K021022 · GGN
Instrumentation Laboratory CO
Hematology · 46d
Cleared May 14, 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023 · GGN
Instrumentation Laboratory CO
Hematology · 46d
Cleared May 14, 2002
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021058 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 42d
Cleared May 14, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021059 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 42d
Cleared May 14, 2002
SL-PLUS LATERALIZED STEM
K021178 · JDI
Plus Orthopedics
Orthopedic · 29d
Cleared May 14, 2002
SIMPLICITY QD EASY P INFUSION SET
K021296 · FPA
Sterling Medivations, Inc.
General Hospital · 20d
Cleared May 14, 2002
GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
K021308 · LZA
Glovco (M) Sdn. Bhd.
General Hospital · 19d
Cleared May 14, 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · FRN
Abbott Laboratories
General Hospital · 15d
Cleared May 13, 2002
AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
K020579 · GEI
Aaron Medical Industries
General & Plastic Surgery · 81d