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
129169–129192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K892754 · LYZ
Baxter Healthcare Corp
General Hospital · 155d
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES (POLY)
K892771 · LZA
P.A. Research Corp.
General Hospital · 155d
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES
K892774 · LYY
Liaoning-Usa Corp.
General Hospital · 155d
Cleared Sep 13, 1989
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000
K892878 · DSP
Kontron Instruments, Inc.
Cardiovascular · 147d
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES
K892953 · LYY
Masju Sdn. Bhd.
General Hospital · 154d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893115 · LYY
Naturub Sdn. Bhd.
General Hospital · 152d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893154 · LYY
Magna Intl., Inc.
General Hospital · 122d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893155 · LYY
Success Development (Usa) Co., Inc.
General Hospital · 152d
Cleared Sep 13, 1989
TOPCLEAN PATIENT EXAMINATION GLOVES
K893158 · LYY
Pt. Herlin Dharma Persada
General Hospital · 152d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893292 · LYY
Mahagewang Sdn Bhd
General Hospital · 148d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893293 · LYY
Toptech Industry Corp.
General Hospital · 148d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893302 · LYY
Gromax Rubber Industry Co., Ltd.
General Hospital · 148d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893303 · LYY
Marble King Corp.
General Hospital · 148d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893304 · LYY
Lakewood Ent., Ltd.
General Hospital · 148d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893306 · LYY
Acefit Intl., Inc.
General Hospital · 148d
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES
K893593 · LYY
Strong Will Sdn Bhd
General Hospital · 127d
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES
K893607 · LYY
Wedana Rubber Products
General Hospital · 126d
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES
K893618 · LYY
Tenma Co. , Ltd.
General Hospital · 126d
Cleared Sep 13, 1989
PATIENT EXAM GLOVES(MFG: SHANGHAI HUA LING LAT FAC
K893695 · LYY
Shanghai Industrial Investment Co. ,...
General Hospital · 120d
Cleared Sep 13, 1989
MEDI + FORM EXAM (MFG: GLOVE SEAL SDN BHD)
K893719 · LYY
World Impex Corp.
General Hospital · 119d
Cleared Sep 13, 1989
CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE
K893867 · DQA
Spacelabs, Inc.
Anesthesiology · 110d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K894079 · LYY
Target USA, Inc.
General Hospital · 97d
Cleared Sep 13, 1989
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
K894180 · CIT
Abbott Laboratories
Chemistry · 89d
Cleared Sep 13, 1989
REP TM SPE (PONCEAU S) PROCEDURES
K894585 · CEF
Helena Laboratories
Chemistry · 51d