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
9673–9696 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 09, 1996
HEELBO QUILTED TORSO RESTRAINT
K963108 · FMQ
Hollister, Inc.
General Hospital · 58d
Cleared Oct 09, 1996
HEELBO ICU 911 BLAZER SLEEVED JACKET
K963237 · FMQ
Heelbo, Inc.
General Hospital · 51d
Cleared Oct 09, 1996
SLEEPER JACKET/HOUDINI SAFETY SLEEPER
K963457 · FMQ
Skil-Care Corp.
General Hospital · 36d
Cleared Oct 09, 1996
ROLL BELT
K963460 · FMQ
Skil-Care Corp.
General Hospital · 36d
Cleared Oct 08, 1996
AIR-MEDEX I
K961769 · FNM
Robert Gold Assoc.
General Hospital · 153d
Cleared Oct 08, 1996
GLASS SYRINGE
K962042 · FMF
Ispg, Inc.
General Hospital · 133d
Cleared Oct 08, 1996
Q-TIPS, FAICHNEY, PRIVATE LABEL
K962497 · FLL
Faichney Medical Co.
General Hospital · 104d
Cleared Oct 08, 1996
LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER
K963456 · FMQ
Skil-Care Corp.
General Hospital · 35d
Cleared Oct 07, 1996
LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)
K961415 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 186d
Cleared Oct 07, 1996
LATEX PATIENT EXAMINATION GLOVE (PINK)
K961602 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 186d
Cleared Oct 07, 1996
2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD
K962286 · FXX
Berkley Medical Resources, Inc.
General Hospital · 115d
Cleared Oct 07, 1996
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV....
K962709 · FRN
Sigma Intl.
General Hospital · 87d
Cleared Oct 07, 1996
T.B.Q.
K962739 · LRJ
Convatec, A Division of E.R. Squibb &...
General Hospital · 84d
Cleared Oct 07, 1996
2000 MODULAR THIRTY-NINE
K962763 · FNL
Equi-Tron Mfg., Inc.
General Hospital · 83d
Cleared Oct 07, 1996
CATHETER INSERTION TRAY
K962849 · LJS
Medcare Medical Group, Inc.
General Hospital · 77d
Cleared Oct 07, 1996
MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K962956 · KZE
Medi-Ject Corp.
General Hospital · 69d
Cleared Oct 07, 1996
DOUBLE SUPPORT PONCHO/SLIDER PONCHO
K963447 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
ECONO BELT
K963448 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
PELVIC HOLDER
K963449 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST
K963450 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE...
K963454 · FMQ
Skil-Care Corp.
General Hospital · 34d
Cleared Oct 07, 1996
MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL...
K963583 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 31d
Cleared Oct 04, 1996
SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET
K962663 · MEB
Solopak Medical Products, Inc.
General Hospital · 88d
Cleared Oct 04, 1996
SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET
K963355 · MEB
Solopak Medical Products, Inc.
General Hospital · 39d