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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
3841–3864 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 09, 1994
EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM
K932208 · DWF
Baxter Healthcare Corp
Cardiovascular · 460d
Cleared Aug 08, 1994
OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC
K921846 · LNX
Oceania Health Care Systems, Inc.
General Hospital · 843d
Cleared Aug 05, 1994
7300 NASAL CPAP SYSTEM
K943509 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 16d
Cleared Aug 03, 1994
LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'S
K943184 · EFQ
Lorons International Corp.
General & Plastic Surgery · 33d
Cleared Aug 03, 1994
LORREX IV SPONGES, STERILE 2'S
K942824 · EFQ
Lorrex Health Products
General & Plastic Surgery · 50d
Cleared Aug 03, 1994
LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS
K942692 · EFQ
Lorons International Corp.
General & Plastic Surgery · 57d
Cleared Jul 28, 1994
PENTHOUSE CONDOMS
K933153 · HIS
Kuron Health Products Corp.
Obstetrics & Gynecology · 394d
Cleared Jul 27, 1994
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116 · HAE
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 26, 1994
CURAFIL WOUND GEL DRESSING
K943073 · MGQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 28d
Cleared Jul 26, 1994
SURGICAL TIP CLEANER
K942577 · GEI
White Knight Healthcare
General & Plastic Surgery · 56d
Cleared Jul 26, 1994
SARNS FILTERED VENOUS RESERVIOR MODIFICATION
K941654 · DTP
3M Health Care, Sarns
Cardiovascular · 112d
Cleared Jul 25, 1994
AUTO SUTURE PITUITARY SPINAL RONGEUR
K943115 · HAO
United States Surgical, A Division of...
Neurology · 28d
Cleared Jul 25, 1994
AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR
K930867 · LKF
United States Surgical, A Division of...
Obstetrics & Gynecology · 521d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL DISSECTOR
K942971 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL ELEVATOR
K942970 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL NERVE HOOK
K942969 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL OSTEOTOME
K942968 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 20, 1994
AUTO SUTURE SPINAL CURETTE
K942967 · HAO
United States Surgical, A Division of...
Neurology · 30d
Cleared Jul 14, 1994
COMFORT KEYBOARD SYSTEM
K930044 · ILQ
Health Care Keyboard Co., Inc.
Physical Medicine · 555d
Cleared Jul 07, 1994
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
K935659 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 225d
Cleared Jul 07, 1994
UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI
K932984 · HIS
Sime Health, Ltd.
Obstetrics & Gynecology · 384d
Cleared Jul 07, 1994
COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
K932983 · HIS
Sime Health, Ltd.
Obstetrics & Gynecology · 384d
Cleared Jul 07, 1994
SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
K932982 · HIS
Sime Health, Ltd.
Obstetrics & Gynecology · 384d
Cleared Jul 06, 1994
ALICE
K922106 · OLV
Healthdyne, Inc.
Neurology · 792d