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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
129553–129576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1989
TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD
K893912 · LCD
Technicon Instruments Corp.
Toxicology · 83d
Cleared Aug 21, 1989
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD
K893913 · KLB
Technicon Instruments Corp.
Toxicology · 83d
Cleared Aug 21, 1989
NON-STERILE LATEX EXAMINATION GLOVES
K894013 · LYY
Nova Rubber Glove Industries Sdn. Bhd.
General Hospital · 76d
Cleared Aug 21, 1989
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER
K894069 · JQW
Abbott Laboratories
Chemistry · 74d
Cleared Aug 21, 1989
MADEGOM LTDA. DENTAL DAM
K894120 · EIE
Madegom
Dental · 70d
Cleared Aug 21, 1989
LIQUID CHROMATOGRAPHY COLUMNS
K894141 · DPM
Supelco, Inc.
Toxicology · 69d
Cleared Aug 21, 1989
MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
K894224 · LSR
Mardx Diagnostics, Inc.
Microbiology · 63d
Cleared Aug 21, 1989
DENLEY ANTHOS 2001 READER
K894270 · JJQ
Denley Instruments, Inc.
Chemistry · 60d
Cleared Aug 21, 1989
DENLEY WELLDILL 3
K894272 · JQW
Denley Instruments, Inc.
Chemistry · 60d
Cleared Aug 21, 1989
MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
K894293 · LSR
Mardx Diagnostics, Inc.
Microbiology · 59d
Cleared Aug 21, 1989
MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS
K894438 · GFF
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 35d
Cleared Aug 21, 1989
LATEX EXAMINATION GLOVES
K894456 · LYY
P T Perkasa Rubber Industries
General Hospital · 34d
Cleared Aug 21, 1989
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K894463 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 32d
Cleared Aug 21, 1989
LATEX EXAMINATION GLOVES
K894473 · LYY
Protech Industries Co., Ltd.
General Hospital · 34d
Cleared Aug 21, 1989
EPILATION NEEDLE
K894771 · KCW
Precision Electrolysis Needles, Inc.
General & Plastic Surgery · 26d
Cleared Aug 21, 1989
MONODEX
K894793 · KTN
Cenogenics Corp.
Immunology · 24d
Cleared Aug 18, 1989
LATEX PATIENT EXAMINATION GLOVE
K891018 · LYY
U.S. Medical Supply, Inc.
General Hospital · 171d
Cleared Aug 18, 1989
PATIENT EXAM GLOVES (MFG. PALMBASE RUBBER MFG.)
K891811 · LYY
Mulpha Intl. Trading Corp. Bhd.
General Hospital · 148d
Cleared Aug 18, 1989
PATIENT EXAM GLOVES (MFG. GETAH GAYAL)
K891812 · LYY
Mulpha Intl. Trading Corp. Bhd.
General Hospital · 148d
Cleared Aug 18, 1989
PATIENT EXAM GLOVES (MFG. AEK RUBBER PRODUCTS)
K891813 · LYY
Mulpha Intl. Trading Corp. Bhd.
General Hospital · 148d
Cleared Aug 18, 1989
PATIENT EXAM GLOVES (MFG. HEALTHCARE GLOVES)
K891816 · LYY
Mulpha Intl. Trading Corp. Bhd.
General Hospital · 148d
Cleared Aug 18, 1989
PATIENT EXAM GLOVES (MFG. TERANG NUSA)
K891817 · LYY
Mulpha Intl. Trading Corp. Bhd.
General Hospital · 148d
Cleared Aug 18, 1989
LATEX EXAMINATION GLOVES
K893104 · LYY
Chuen Her Industries Co., Ltd.
General Hospital · 126d
Cleared Aug 18, 1989
LATEX EXAMINATION GLOVES
K893114 · LYY
Anro Corp. Sdn Bhd
General Hospital · 126d