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
7825–7848 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 24, 2000
PDT DOSECALCULATOR, MODEL 80000
K000418 · NDC
Retinalabs.Com
General Hospital · 259d
Cleared Oct 24, 2000
SIMPLICITY SOFT INFUSION SET
K002492 · FPA
Sterling Medivations, Inc.
General Hospital · 71d
Cleared Oct 24, 2000
DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE,...
K002975 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 32d
Cleared Oct 24, 2000
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · LYZ
Medline Industries, Inc.
General Hospital · 21d
Cleared Oct 23, 2000
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K000838 · LYY
P.T. Healthcare Glovindo
General Hospital · 223d
Cleared Oct 20, 2000
DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K002814 · LYZ
Shanghai PM Plastics Enterise Co., Ltd.
General Hospital · 39d
Cleared Oct 20, 2000
BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/...
K994276 · LZA
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Oct 20, 2000
BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN,...
K994281 · LZA
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Oct 19, 2000
0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
K000632 · FOZ
Avitro, LLC
General Hospital · 238d
Cleared Oct 19, 2000
THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD
K001795 · FOZ
Avitro, LLC
General Hospital · 127d
Cleared Oct 19, 2000
JETCAN HUBER NEEEDLE SET
K002471 · FPA
Pfm Produkte Fur Die Medizin AG
General Hospital · 69d
Cleared Oct 19, 2000
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K002933 · KGO
Maxxim Medical
General Hospital · 29d
Cleared Oct 19, 2000
SPIRIT ACUPUNCTURE NEEDLE
K003010 · MQX
United Pacific Co., Ltd.
General Hospital · 23d
Cleared Oct 19, 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · FPA
Baxter Healthcare Corp
General Hospital · 3d
Cleared Oct 18, 2000
SUREONE INSULIN SYRINGE
K002921 · FMF
Hosuk Co., Ltd.
General Hospital · 29d
Cleared Oct 16, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K002870 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 33d
Cleared Oct 16, 2000
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200...
K002922 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 27d
Cleared Oct 13, 2000
SIMPLICITY DISPOSABLE PEN NEEDLE
K002180 · FMI
Sterling Medivations, Inc.
General Hospital · 86d
Cleared Oct 13, 2000
PACIFIER THERMOMETER MODELS VT-901F, VT901C
K002562 · FLL
Valeo Corp.
General Hospital · 57d
Cleared Oct 12, 2000
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
K002745 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 37d
Cleared Oct 11, 2000
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
K002746 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 36d
Cleared Oct 10, 2000
ATOM INFA WARMER V-505
K002355 · FMT
Atom Medical Corp
General Hospital · 69d
Cleared Oct 03, 2000
BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID
K002213 · FMI
Hunter Research Laboratories, Inc.
General Hospital · 74d
Cleared Oct 03, 2000
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K002568 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 46d