FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
86545–86568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 16, 1999
IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
K984523 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 57d
Cleared Feb 16, 1999
MICROTAC-BONE ANCHOR SYSTEM
K990160 · MBI
Influence, Inc.
Orthopedic · 28d
Cleared Feb 16, 1999
MAGNETIC TIBC KIT
K990216 · JMO
Reference Diagnostics, Inc.
Chemistry · 25d
Cleared Feb 16, 1999
DIMENSION DRUG CALIBRATOR II, MODEL DC49B
K990255 · DKB
Dade Behring, Inc.
Toxicology · 20d
Cleared Feb 12, 1999
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
K980723 · MGZ
Vascutech, Inc.
Cardiovascular · 353d
Cleared Feb 12, 1999
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
K981913 · LSR
Chembio Diagnostic Systems, Inc.
Microbiology · 256d
Cleared Feb 12, 1999
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
K982333 · MSD
Cook, Inc.
Gastroenterology & Urology · 225d
Cleared Feb 12, 1999
MEDCO ASPIRATOR IV
K982371 · BTA
Medco Mfg.
General & Plastic Surgery · 220d
Cleared Feb 12, 1999
SCI-PHARM DFV VARNISH
K982915 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 177d