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
8737–8760 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 20, 1998
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888 · LJT
Boston Scientific Corp
General Hospital · 64d
Cleared Oct 19, 1998
DISETRONIC PEN
K982966 · FMF
Disetronic Medical Systems
General Hospital · 55d
Cleared Oct 19, 1998
SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER,...
K983406 · FLL
Banta Healthcare Group, Ltd.
General Hospital · 21d
Cleared Oct 16, 1998
UROSURGE UROTHERM FLUID WARMING SYSTEM
K965136 · LHC
Princeton Regulatory Assoc.
General Hospital · 662d
Cleared Oct 16, 1998
PENETREASE
K980078 · FMF
P.T. Panca Pusaka Deli
General Hospital · 281d
Cleared Oct 16, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1
K983409 · FOZ
Hdc Corp.
General Hospital · 18d
Cleared Oct 15, 1998
VINYL PATIENT EXAMINATION GLOVE, POWDERED
K981360 · LYZ
Glormed Intl., Inc.
General Hospital · 184d
Cleared Oct 15, 1998
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50...
K982872 · LYY
Tg Medical Sdn. Bhd.
General Hospital · 62d
Cleared Oct 13, 1998
BREATHE EASY, MODELS AD AND CD
K981841 · FRF
Respiraid , Ltd.
General Hospital · 140d
Cleared Oct 13, 1998
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
K983175 · LYY
Ultrawin Sdn Bhd
General Hospital · 33d
Cleared Oct 09, 1998
DISPOSABLE VINYL EXAM GLOVES, POWDERED
K982687 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 67d
Cleared Oct 09, 1998
MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K982691 · LYY
Perusahaan Intan Emas Sdn. Bhd.
General Hospital · 67d
Cleared Oct 08, 1998
STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR
K982547 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 79d
Cleared Oct 06, 1998
MICROFUSE DUAL RATE INFUSER
K983321 · FRN
Baxa Corp.
General Hospital · 14d
Cleared Oct 05, 1998
VAIL 1000 ENCLOSED BED
K982783 · FNL
Vail Products, Inc.
General Hospital · 59d
Cleared Oct 01, 1998
VYGON DOUBLE LUMEN UMBILICAL CATHETER
K981630 · FOS
Schiff & Co.
General Hospital · 147d
Cleared Sep 30, 1998
DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A
K981337 · FLL
Mesure Technology
General Hospital · 170d
Cleared Sep 30, 1998
SYNTHETIC EXAMINATION GLOVE, POWDERED
K981876 · LYZ
Hsing YI Plastics Processing Co, Ltd.
General Hospital · 125d
Cleared Sep 30, 1998
METRON QA-IDS I.V. PUMP TESTER
K982020 · FRN
Metron U.S., Inc.
General Hospital · 113d
Cleared Sep 30, 1998
OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
K982256 · MEB
Mckinley, Inc.
General Hospital · 96d
Cleared Sep 30, 1998
NITRILE PATIENT EXAMINATION GLOVE
K982440 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 78d
Cleared Sep 30, 1998
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K982704 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 58d
Cleared Sep 30, 1998
DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER
K982781 · MMK
Thermal Waste Technology, Inc.
General Hospital · 54d
Cleared Sep 30, 1998
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982806 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 50d