FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

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

Filters: Cleared only ×
175,230 results
157249–157272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1983
AUTO PREP
K830319 · JQW
Pm America, Inc.
Chemistry · 57d
Cleared Mar 29, 1983
DAVOL SURGICAL SUCTION IRRIGATION INSTR
K830386 · FQH
C.R. Bard, Inc.
General Hospital · 53d
Cleared Mar 29, 1983
ARM CUSHION
K830427 · KIC
Maddak, Inc.
Physical Medicine · 48d
Cleared Mar 29, 1983
EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-
K830509 · BTO
Frederic J. Toye, M.D.
Anesthesiology · 40d
Cleared Mar 29, 1983
DISPERSIVE ELECTRODE
K830545 · GEI
C.R. Bard, Inc.
General & Plastic Surgery · 35d
Cleared Mar 29, 1983
FEB TEST
K830564 · CFM
Wako Chemicals USA, Inc.
Chemistry · 34d
Cleared Mar 29, 1983
PRE VUE
K830573 · FOZ
Taut, Inc.
General Hospital · 34d
Cleared Mar 29, 1983
RENATRON DIALYZER REPROCESSING SYS
K830574 · LIF
Renal Systems, Inc.
Gastroenterology & Urology · 34d
Cleared Mar 29, 1983
FLAT SUCTION DRAIN
K830610 · GBC
Sil-Med Corp.
General & Plastic Surgery · 32d
Cleared Mar 29, 1983
CHEMO-TABLE
K830612 · FWZ
Fabrications Unltd.
General & Plastic Surgery · 29d
Cleared Mar 29, 1983
H1210
K830647 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 28d
Cleared Mar 29, 1983
H1207
K830648 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 28d
Cleared Mar 29, 1983
THORAX-KLEX CHEST DRAINAGE UNIT
K830671 · KDQ
C.R. Bard, Inc.
General Hospital · 25d
Cleared Mar 29, 1983
EMPTY DIALYSATE CONTAINER BB-69
K830689 · FKX
Delmed, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 29, 1983
BETA-COTE B-HCG PREGNANCY SCREENING SYS
K830695 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 22d
Cleared Mar 29, 1983
ARGYLE SUCTION CATHETERS
K830709 · BSY
Sherwood Medical Co.
Anesthesiology · 22d
Cleared Mar 29, 1983
ARGYLE SILICONE SALEM SUMP TUBE
K830710 · KNT
Sherwood Medical Co.
Gastroenterology & Urology · 22d
Cleared Mar 29, 1983
C-DAK ARTIFICIAL KIDNEY
K830729 · KOC
Cordis Corp.
Gastroenterology & Urology · 21d
Cleared Mar 29, 1983
PRO-GUARD
K830739 · FRG
Surgicot, Inc.
General Hospital · 21d
Cleared Mar 29, 1983
HOT/ICE
K830757 · ILO
Thermo Temp, Inc.
Physical Medicine · 19d
Cleared Mar 29, 1983
ABBOTT PATIENT ASSIST DEVICE
K830766 · FKX
Abbott Laboratories
Gastroenterology & Urology · 19d
Cleared Mar 29, 1983
PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE
K830792 · GZJ
Bomed Medical Mfr., Ltd.
Neurology · 15d
Cleared Mar 28, 1983
PHYSICIANS CHOICE SILICONE EAR PUTTY
K823921 · LDG
Santa Barbara Medco, Inc.
Ear, Nose, Throat · 90d
Cleared Mar 28, 1983
CART
K823925
Medical Assoc. Intl., Inc.
General & Plastic Surgery · 89d