FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
132001–132024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1989
CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
K891983 · KCT
Medical Dynamics, Inc.
General Hospital · 22d
Cleared Apr 18, 1989
HEMAWIPE SYSTEM, THE CIVILIZED TEST
K884206 · KHE
Labeltape Meditect, Inc.
Hematology · 194d
Cleared Apr 18, 1989
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 141d
Cleared Apr 18, 1989
MARDX LYME DISEASE IGG IFA TEST SYSTEM
K890053 · LSR
Mardx Diagnostics, Inc.
Microbiology · 102d
Cleared Apr 18, 1989
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · GKZ
Abbott Diagnostics
Hematology · 77d
Cleared Apr 18, 1989
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
K890615 · JHI
Quidel Corp.
Chemistry · 70d
Cleared Apr 18, 1989
HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196
K890773 · CEO
Hichem Diagnostics
Chemistry · 62d
Cleared Apr 18, 1989
PATIENT EXAMINATION GLOVE
K890976 · LYY
Cranberry (M) Sdn. Bhd.
General Hospital · 50d
Cleared Apr 18, 1989
CARERITE FACE MASK
K891141 · FXX
Cost Rite Health Products, Inc.
General Hospital · 46d
Cleared Apr 18, 1989
IRON REAGENT
K891155 · CFM
Medical Analysis Systems, Inc.
Chemistry · 43d
Cleared Apr 18, 1989
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385 · DEW
Vitek Systems, Inc.
Chemistry · 40d
Cleared Apr 18, 1989
CORE BIOPSY NEEDLE, CATALOG CODE #54006
K891537 · GDM
Dlp, Inc.
General & Plastic Surgery · 32d
Cleared Apr 18, 1989
3MM DISPOSABLE SPECULA
K891589 · FXG
Semantodontics, Inc.
General & Plastic Surgery · 29d
Cleared Apr 17, 1989
DOCTOR KOLYNOS TOOTHBRUSH
K882572 · EFW
Whitehall Laboratories, Inc.
Dental · 299d
Cleared Apr 17, 1989
MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES
K884097 · ODC
Circon Acmi
Gastroenterology & Urology · 201d
Cleared Apr 17, 1989
DICOR CERAMIC INLAY - NEW TECHNIC
K884166 · ELW
Dentsply Intl.
Dental · 195d
Cleared Apr 17, 1989
APEX 115 NUCLEAR MEDICINE PROCESSOR
K884672 · IYX
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
APEX 415 ANGER CAMERA
K884674 · IYX
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
APEX 609R ANGER CAMERA
K884675 · IYX
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
FRASTEC CONFORMANT DRESSING, VARIOUS SIZES
K885325 · NAD
Frastec Wound Care Products, Inc.
General & Plastic Surgery · 110d
Cleared Apr 17, 1989
HEMO-CATH SILICONE DOUBLE LUMEN CATHETER
K890029 · LFJ
Medical Components, Inc.
Gastroenterology & Urology · 103d
Cleared Apr 17, 1989
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
K890300 · HQE
CooperVision, Inc.
Ophthalmic · 88d
Cleared Apr 17, 1989
BCM-ARC 105 X-RAY MOBILE UNIT
K890306 · IZL
B C Medical , Ltd.
Radiology · 84d
Cleared Apr 17, 1989
MENTOR ANTERIOR SEGMENT VITRECTOR
K890595 · HKP
Mentor O & O, Inc.
Ophthalmic · 70d