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
7873–7896 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 07, 2000
P.O.P. PAIN KIT
K001342 · MEB
Post Operative Pain Management
General Hospital · 133d
Cleared Sep 07, 2000
I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411
K001872 · FPA
Codan US Corp.
General Hospital · 79d
Cleared Sep 05, 2000
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K002380 · FRN
Baxter Healthcare Corp
General Hospital · 32d
Cleared Sep 01, 2000
EQUIPMENT DRAPES
K002508 · KKX
Allegiance Healthcare Corp.
General Hospital · 17d
Cleared Aug 30, 2000
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS
K001300 · DWL
Confection Medicale D.R., Inc.
General Hospital · 128d
Cleared Aug 29, 2000
AVID-NIT LOSS OF RESISTANCE SYRINGE
K001731 · FMF
Avid Medical, Inc.
General Hospital · 83d
Cleared Aug 29, 2000
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
K002138 · FPA
Maersk Medical A/S
General Hospital · 43d
Cleared Aug 29, 2000
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
K002401 · MED
Advanced Sterilization Products
General Hospital · 22d
Cleared Aug 23, 2000
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
K000355 · JOJ
Minnesota Mining and Mfg. Co.
General Hospital · 201d
Cleared Aug 23, 2000
PALM PUMP
K002434 · MEA
Sorenson Medical, Inc.
General Hospital · 14d
Cleared Aug 23, 2000
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
K993950 · FLL
Nien Made Electrnics Corp.
General Hospital · 275d
Cleared Aug 22, 2000
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1
K000969 · FLL
Microlife Corp.
General Hospital · 148d
Cleared Aug 22, 2000
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR...
K002065 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 46d
Cleared Aug 22, 2000
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
K002340 · LYZ
Glormed Intl., Inc.
General Hospital · 21d
Cleared Aug 18, 2000
PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
K001827 · FPA
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
PARADIGM 1.5ML RESERVOIR, MODEL 326
K001828 · FRN
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
MINIMED PARADIGM INSULIN PUMP, MODEL 511
K001829 · FRN
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318
K001832 · FPA
Minimed, Inc.
General Hospital · 63d
Cleared Aug 17, 2000
STACKHOUSE LENS HOOD, MODEL SA-700/F
K000605 · FYA
Stackhouse, Inc.
General Hospital · 176d
Cleared Aug 17, 2000
OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE
K001858 · KKX
China Nantong Guangda Textile Co., Ltd.
General Hospital · 59d
Cleared Aug 17, 2000
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM
K002314 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 17d
Cleared Aug 17, 2000
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
K993042 · MED
Medivators, Inc.
General Hospital · 342d
Cleared Aug 16, 2000
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000
K001106 · FPA
Creative Plastic Technology
General Hospital · 133d
Cleared Aug 15, 2000
CHARTER MEDICAL NEONATAL SYRINGE SET
K000685 · BRZ
Charter Medical, Ltd.
General Hospital · 168d