FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84073–84096 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1999
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
K994045 · LCP
Primus Corp.
Hematology · 22d
Cleared Dec 21, 1999
E. HISTOLYTICA II
K994101 · KHW
Techlab, Inc.
Microbiology · 15d
Cleared Dec 21, 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K994110 · DFC
Diasorin/American Standard Companies
Chemistry · 15d
Cleared Dec 21, 1999
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
K994175 · HBB
Sodemsystems
Neurology · 11d
Cleared Dec 21, 1999
SYNTHES CERVIFIX SYSTEM
K994187 · KWP
Synthes (Usa)
Orthopedic · 8d
Cleared Dec 20, 1999
C3 MININEPH ANTISERUM
K981783 · CZW
The Binding Site, Ltd.
Immunology · 579d
Cleared Dec 20, 1999
C4 MININEPH ANTISERUM
K981785 · DBI
The Binding Site, Ltd.
Immunology · 579d
Cleared Dec 20, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
K981915 · JJY
The Binding Site, Ltd.
Immunology · 567d
Cleared Dec 20, 1999
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
K982100 · CFN
The Binding Site, Ltd.
Immunology · 553d
Cleared Dec 20, 1999
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
K990849 · LPH
Howmedica Osteonics Corp.
Orthopedic · 280d
Cleared Dec 20, 1999
POLLER CALIBRANTS
K991439 · GGN
European Concerted Action on...
Hematology · 238d
Cleared Dec 20, 1999
HANG UPS POWER II
K991835 · ITH
Stl Intl., Inc.
Physical Medicine · 206d
Cleared Dec 20, 1999
EIS THREADED SCREW FRACTURE FIXATION
K991964 · HWC
Groupe Lepine
Orthopedic · 193d
Cleared Dec 20, 1999
EMBOLIZATION COIL SYSTEM
K992121 · KRD
Cook, Inc.
Cardiovascular · 180d
Cleared Dec 20, 1999
LACTOSORB TRAUMA PLATING SYSTEM
K992355 · HRS
Biomet, Inc.
Orthopedic · 159d
Cleared Dec 20, 1999
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA...
K992531 · JOZ
Accumetrics, Inc.
Hematology · 145d
Cleared Dec 20, 1999
INTERFACE MODULE IDDD
K992635 · KRI
Stoeckert Instrumente
Cardiovascular · 136d
Cleared Dec 20, 1999
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
K993048 · PSZ
Roche Diagnostics Corp.
Microbiology · 101d
Cleared Dec 20, 1999
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
K993096 · CHH
Lifestream Technologies, Inc.
Chemistry · 206d
Cleared Dec 20, 1999
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169 · DRG
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Dec 20, 1999
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289 · KTT
Smith & Nephew, Inc.
Orthopedic · 80d
Cleared Dec 20, 1999
SADDLE SHAPED PATELLA
K993371 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 74d
Cleared Dec 20, 1999
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
K993375 · KRX
Clinical Diagnostic Solutions, Inc.
Hematology · 74d
Cleared Dec 20, 1999
LATEX EXAMINATION POWDERED GLOVES
K993386 · LYY
Great Glove Sdn Bhd
General Hospital · 73d