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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145753–145776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1986
NELSON-JUNG PLEURAL CATH
K854812 · GBW
Research Medical, Inc.
General & Plastic Surgery · 70d
Cleared Feb 11, 1986
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
K854945 · CDD
Ciba Corning Diagnostics Corp.
Hematology · 63d
Cleared Feb 11, 1986
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
K854987 · HWE
Richard Wolf Medical Instruments Corp.
Orthopedic · 61d
Cleared Feb 11, 1986
EMDS GLUCOSE TEST PACK ITEM 67656/95
K855080 · LFR
Em Diagnostic Systems, Inc.
Chemistry · 54d
Cleared Feb 11, 1986
KMW HIP PROSTHESIS POROUS COATED
K855123
Kirkschner Medical Corp.
Orthopedic · 50d
Cleared Feb 11, 1986
COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER
K855149 · JJQ
Hyperion, Inc.
Chemistry · 47d
Cleared Feb 11, 1986
GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
K855203 · FMK
Miles Laboratories, Inc.
General & Plastic Surgery · 47d
Cleared Feb 11, 1986
FEMORAL HEMI-HIP PROSTHESES
K855228 · KWL
Orthopaedic Device Corp.
Orthopedic · 43d
Cleared Feb 11, 1986
DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM
K860021 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 39d
Cleared Feb 11, 1986
CALCIUM (CPC) REAGENT SET
K860044 · CIC
Sterling Diagnostics, Inc.
Chemistry · 36d
Cleared Feb 11, 1986
SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS
K860074
Warsaw Orthopedic, Inc.
Orthopedic · 35d
Cleared Feb 11, 1986
CPK REAGENT SET (COLORIMETRIC)
K860096 · CGS
Sterling Diagnostics, Inc.
Chemistry · 32d
Cleared Feb 11, 1986
THERAPEUTIC DRUG (TDM) CALIBRATOR
K860097 · DIF
Instrumentation Laboratory CO
Toxicology · 32d
Cleared Feb 11, 1986
GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET
K860110 · CKA
Technostics Intl.
Chemistry · 29d
Cleared Feb 11, 1986
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.
K860141 · LAR
American Dade
Toxicology · 28d
Cleared Feb 11, 1986
URIC ACID REAGENT SET (COLORIMETRIC)
K860142 · LFQ
Sterling Diagnostics, Inc.
Chemistry · 28d
Cleared Feb 11, 1986
QWIKSPIN (TM)
K860172 · JQC
Norfolk Scientific, Inc.
Chemistry · 25d
Cleared Feb 11, 1986
ALLEN UNIVERSAL STIRRUP
K860177 · BWN
Edgewater Medical Equipment Systems
General & Plastic Surgery · 25d
Cleared Feb 11, 1986
ALBUMIN REAGENT KIT
K860213 · CIX
Bio-Analytics Laboratories, Inc.
Chemistry · 20d
Cleared Feb 11, 1986
MAGNESIUM REAGENT SET
K860215 · JGJ
Sterling Diagnostics, Inc.
Chemistry · 20d
Cleared Feb 11, 1986
METRICOM
K860225 · LDK
Far Orthopedics, Inc.
Physical Medicine · 20d
Cleared Feb 11, 1986
AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA
K860251 · CEC
Amersham Corp.
Chemistry · 18d
Cleared Feb 11, 1986
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA
K860252 · CDP
Amersham Corp.
Chemistry · 18d
Cleared Feb 11, 1986
XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
K860285 · KNT
Vygon Corp.
Gastroenterology & Urology · 14d