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
87049–87072 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)
K990285 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 20d
Cleared Feb 18, 1999
SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O
K990339 · IYN
Hewlett-Packard Co.
Radiology · 15d
Cleared Feb 17, 1999
GLIADIN ANTIBODIES ELISA
K973910 · MST
Genesis Diagnostics , Ltd.
Immunology · 491d
Cleared Feb 17, 1999
BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM
K982721 · JEY
Bionx Implants, Inc.
Dental · 197d
Cleared Feb 17, 1999
CBC-5D HEMATOLOGY CONTROL
K983032 · JPK
R&D Systems, Inc.
Hematology · 170d
Cleared Feb 17, 1999
CARE BAND ANTIBACTERIAL BANDAGES
K983368 · KGX
Aso Corp.
General & Plastic Surgery · 146d
Cleared Feb 17, 1999
BIPORE BALLOON DILATATION CATHETER
K983650 · LIT
Bipore, Inc.
Cardiovascular · 124d
Cleared Feb 17, 1999
EXONIX
K984199 · IMI
Fibra Sonics, Inc.
Physical Medicine · 85d
Cleared Feb 17, 1999
POWDERED NITRILE EXAMINATION GLOVES
K984615 · LZA
Shiva Medicare , Ltd.
General Hospital · 50d
Cleared Feb 17, 1999
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
K990046 · GJT
Pacific Hemostasis
Hematology · 41d
Cleared Feb 16, 1999
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
K981829 · GNP
Diamedix Corp.
Microbiology · 270d
Cleared Feb 16, 1999
IS EBV-EA-D IGG ELISA TEST SYSTEM
K981831 · GNP
Diamedix Corp.
Microbiology · 270d
Cleared Feb 16, 1999
THE FREMSTAD RING
K982599 · HOZ
Ophthalmic Solutions, LLC
Ophthalmic · 204d
Cleared Feb 16, 1999
CK
K983070 · CGS
Abbott Laboratories
Chemistry · 167d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
K984075 · LCX
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY URINE TEST
K984076 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY COMBO TEST
K984077 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
K984079 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
K984080 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
K984089 · DSI
Zymed Medical Instrumentation
Cardiovascular · 92d
Cleared Feb 16, 1999
BARDEX LUBRI-SIL I.C. FOLEY CATHETER
K984136 · MJC
Bard Medical Div.
Gastroenterology & Urology · 90d
Cleared Feb 16, 1999
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
K984143 · HQC
Fibra Sonics, Inc.
Ophthalmic · 90d
Cleared Feb 16, 1999
QUANTASE PHE/GAL SCREENING ASSAY
K984463 · JNB
Quantase , Ltd.
Chemistry · 62d
Cleared Feb 16, 1999
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K984489 · JWY
Accumed Intl., Inc.
Microbiology · 61d