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

Filters: Cleared only ×
175,820 results
130153–130176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 18, 1989
NIDEK MODEL YC-1200
K893987 · LXS
Nidek, Inc.
Ophthalmic · 74d
Cleared Aug 18, 1989
MADEGOM LTDA. PENROSE DRAIN TUBING
K894119 · GBW
Madegom
General & Plastic Surgery · 67d
Cleared Aug 18, 1989
EXUSORB TRANSPARENT DRESSING
K894274 · KGX
Controlled Therapeutics Corp.
General & Plastic Surgery · 57d
Cleared Aug 18, 1989
STRYKER TRAUMA TRAY
K894470 · KYZ
Stryker Corp.
General Hospital · 31d
Cleared Aug 18, 1989
THE AUTOLET LITE
K894474 · FMK
Ulster Scientific, Inc.
General & Plastic Surgery · 31d
Cleared Aug 18, 1989
DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE
K894728 · HRX
Dyonics, Inc.
Orthopedic · 23d
Cleared Aug 18, 1989
CLOTHINGUARD
K894760 · FYE
Barrier Concepts, Inc.
General & Plastic Surgery · 22d
Cleared Aug 18, 1989
OR TOWEL PACKS
K894764 · KKX
Advance Medical Designs, Inc.
General Hospital · 22d
Cleared Aug 18, 1989
SURGICAL CHISEL/OSTEOTOME
K894785 · KDG
Fdt Precision Machine Co., Inc.
General & Plastic Surgery · 22d
Cleared Aug 17, 1989
LIFECARE MICRO PUMP
K883645 · FRN
Abbott Laboratories
General Hospital · 357d