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
8185–8208 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 03, 2000
CELSITE, MODELS ST401L, ST405L
K994111 · LJT
B. Braun/Mcgaw
General Hospital · 28d
Cleared Dec 30, 1999
DISETRONIC D-TRON INSULIN INFUSION PUMP
K994186 · LZG
Disetronic Medical Systems
General Hospital · 20d
Cleared Dec 29, 1999
LATEX SURGICAL GLOVES, PRE-POWDERED
K993450 · KGO
Fitco Dipped Products Pvt., Ltd.
General Hospital · 78d
Cleared Dec 29, 1999
POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT...
K993529 · LYY
Biografik (Malaysia) Sdn Bhd
General Hospital · 72d
Cleared Dec 29, 1999
POWDER FREE LATEX STERILE SURGICAL GLOVES
K993562 · KGO
Tg Medical Sdn. Bhd.
General Hospital · 69d
Cleared Dec 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES,...
K993621 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 64d
Cleared Dec 29, 1999
DISENTRONIC PENFINE INJECTION PEN NEEDLE
K994197 · FMI
Disetronic Medical Systems
General Hospital · 16d
Cleared Dec 22, 1999
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR...
K994039 · FRN
Abbott Laboratories
General Hospital · 23d
Cleared Dec 20, 1999
LATEX EXAMINATION POWDERED GLOVES
K993386 · LYY
Great Glove Sdn Bhd
General Hospital · 73d
Cleared Dec 20, 1999
GREEN POWDERED LATEX EXAMINATION GLOVES
K993452 · LYY
Top Glove Sdn. Bhd.
General Hospital · 68d
Cleared Dec 20, 1999
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
K993605 · LYY
Top Glove Sdn. Bhd.
General Hospital · 56d
Cleared Dec 20, 1999
PRE-POWDERED VINYL EXAM GLOVE, NON STERILE
K994036 · LYZ
Shanghai Champion Plastic Products...
General Hospital · 21d
Cleared Dec 20, 1999
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4...
K994053 · FYA
Stryker Instruments
General Hospital · 20d
Cleared Dec 16, 1999
SURE-WAY REUSABLE SHARPS CONTAINER
K992626 · FMI
Sure-Way Systems, Inc.
General Hospital · 133d
Cleared Dec 16, 1999
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
K992676 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 128d
Cleared Dec 16, 1999
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
K992681 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 128d
Cleared Dec 16, 1999
PALL SUPOR AEF FILTER
K993379 · FPB
Pall Corp.
General Hospital · 70d
Cleared Dec 16, 1999
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
K993764 · KCT
Medipack Medical Packaging Mfg. Co.
General Hospital · 38d
Cleared Dec 16, 1999
PARAPOST SYSTEM STERILIZABLE ORGANIZER
K993835 · FRG
Coltene/Whaledent, Inc.
General Hospital · 34d
Cleared Dec 13, 1999
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
K993680 · LYZ
Top Glove Sdn. Bhd.
General Hospital · 42d
Cleared Dec 10, 1999
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
K990308 · FOZ
Rocap Div. of Sabratek Corp.
General Hospital · 312d
Cleared Dec 10, 1999
HEPARIN IV FLUSH SYRINGE, 10 U/ML \
K990390 · FOZ
Rocap Div. of Sabratek Corp.
General Hospital · 304d
Cleared Dec 09, 1999
AROMATIC AND FLAVORED TONGUE DEPRESSOR
K992995 · FMA
Aga Plastic Ind. Com. Ltda.
General Hospital · 93d
Cleared Dec 06, 1999
BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
K993255 · FRG
Coltene/Whaledent, Inc.
General Hospital · 69d