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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
113329–113352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1993
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
K931386 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 70d
Cleared May 27, 1993
INJECT-R FILL
K931742 · EKM
Union Broach, Div. Moyco Industries,...
Dental · 50d
Cleared May 26, 1993
EDWARDS ADJUSTABLE CONNECTORS
K915672 · KWP
Scientific Spinal , Ltd.
Orthopedic · 526d
Cleared May 26, 1993
BUBBLE TOCO
K920152 · HFM
Utah Medical Products, Inc.
Obstetrics & Gynecology · 499d
Cleared May 26, 1993
MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
K920706 · FHQ
Retrax
Gastroenterology & Urology · 463d
Cleared May 26, 1993
BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE
K921388 · DSK
Biochem International, Inc.
Cardiovascular · 429d
Cleared May 26, 1993
OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
K921742 · BSZ
Ohmeda Medical
Anesthesiology · 408d
Cleared May 26, 1993
MANUAL SURGICAL INSTRUMENTS
K921925 · GCJ
3M Health Care, Ltd.
General & Plastic Surgery · 397d
Cleared May 26, 1993
KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT
K922789 · CAI
King Systems Corp.
Anesthesiology · 351d
Cleared May 26, 1993
THERMODYN
K923396 · IRT
Nemectron Medical, Inc.
Physical Medicine · 320d
Cleared May 26, 1993
AC-901 I.V. INFUSION DROP COUNTER
K923561 · FLN
Lamtic, Inc.
General Hospital · 313d
Cleared May 26, 1993
CRI ELECTRONIC CONTROL SYSTEM
K924125 · DXX
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 282d
Cleared May 26, 1993
AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET
K924207 · FPA
3M Health Care, Ltd.
General Hospital · 279d
Cleared May 26, 1993
HERITAGE 10
K924293 · JFB
Tjn Manufacturing,Inc.
Physical Medicine · 273d
Cleared May 26, 1993
U.S. MEDICAL PS-7000 DIALYSIS SCALE
K924440 · KOE
U.S. Medical Corp.
Gastroenterology & Urology · 267d
Cleared May 26, 1993
CITSCOPE, BENDABLE -- MODIFICATION
K924494 · HRX
Citation Medical Corp.
Orthopedic · 272d
Cleared May 26, 1993
FT MODEL TABLE W/ELECTRIC HI LO OPTION E
K925563 · INQ
Pro Med Mfg., Inc.
Physical Medicine · 204d
Cleared May 26, 1993
FHB, FHB-T, FHBFLEX, FHBFLEX-T
K925622 · BYD
Icor AB
Anesthesiology · 201d
Cleared May 26, 1993
BATTERY PACK #1014NC
K925674 · FLL
Portable Power Systems, Inc.
General Hospital · 197d
Cleared May 26, 1993
BATTERY PACK #1015NC
K925675 · FLL
Portable Power Systems, Inc.
General Hospital · 197d
Cleared May 26, 1993
INSTRUMENT, MANUAL, GENERAL SURGICAL
K925707 · GEI
Symbiosis Corp.
General & Plastic Surgery · 195d
Cleared May 26, 1993
ANAGO FEM-COOL/FEM-COOL PETITE
K926137 · IMD
Anago, Inc.
Physical Medicine · 170d
Cleared May 26, 1993
LSI6000 THERMAL THERAPY SYSTEM
K926151 · ILO
Burke Neutech, Inc.
Physical Medicine · 170d
Cleared May 26, 1993
ACCESS(R) CORTISOL REAGENTS
K926322 · JFT
Bio-Rad Laboratories, Inc.
Chemistry · 161d