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: General Hospital ×
17,791 results
8233–8256 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 19, 1999
NIL, NITRILE EXAMINATION GLOVE - POWDERED
K993347 · LZA
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 45d
Cleared Nov 19, 1999
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE
K993348 · LZA
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 45d
Cleared Nov 19, 1999
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE
K993419 · LYY
Omnigrace , Ltd.
General Hospital · 38d
Cleared Nov 19, 1999
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100...
K993479 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 36d
Cleared Nov 18, 1999
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
K992697 · LJT
Sims Deltec, Inc.
General Hospital · 99d
Cleared Nov 17, 1999
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
K992678 · LZA
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 99d
Cleared Nov 17, 1999
MODIFIED BLOOD RECIPIENT SET
K993120 · BRZ
Baxter Healthcare Corp
General Hospital · 58d
Cleared Nov 17, 1999
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN
K993133 · LZA
Seal Polymer Industries Bhd.
General Hospital · 58d
Cleared Nov 17, 1999
CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN)
K993134 · LZA
Seal Polymer Industries Bhd.
General Hospital · 58d
Cleared Nov 17, 1999
NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A...
K993326 · LYY
Seal Polymer Industries Bhd.
General Hospital · 44d
Cleared Nov 15, 1999
MINIMED COM-STATION, HARDWARE-7301
K993012 · LZG
Medtronic Minimed
General Hospital · 68d
Cleared Nov 10, 1999
AUTOJET 2 (NON-FIXED NEEDLE TYPE)
K993385 · KZH
Owen Mumford USA, Inc.
General Hospital · 33d
Cleared Nov 10, 1999
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
K993458 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 28d
Cleared Nov 09, 1999
OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K993050 · LZA
Omnigrace , Ltd.
General Hospital · 60d
Cleared Nov 09, 1999
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
K993712 · FMZ
Ohmeda Medical
General Hospital · 6d
Cleared Nov 08, 1999
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT...
K992702 · FMW
Allergy Direct
General Hospital · 88d
Cleared Nov 05, 1999
SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5
K992752 · KGO
Pt. Maja Agung Latexindo
General Hospital · 81d
Cleared Nov 05, 1999
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992797 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 78d
Cleared Nov 05, 1999
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
K992924 · LZA
Latexx Partners Bhd.
General Hospital · 67d
Cleared Nov 05, 1999
DAISY PROTECTED SCALP VEIN SET
K992999 · FPA
Diasol, Inc.
General Hospital · 59d
Cleared Nov 05, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K993187 · FPA
Diasol, Inc.
General Hospital · 43d
Cleared Nov 05, 1999
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED
K993221 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 39d
Cleared Nov 05, 1999
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE
K993222 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 39d
Cleared Nov 05, 1999
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K993247 · LZA
Jda Intl., Inc.
General Hospital · 38d