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
147385–147408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1985
4 X 4' GAUZE PAD
K852857 · EFQ
Cornelia Damsky, Inc.
General & Plastic Surgery · 21d
Cleared Jul 26, 1985
STRETCH BANDAGE
K852858
Cornelia Damsky, Inc.
General & Plastic Surgery · 21d
Cleared Jul 26, 1985
MEDILOG M3
K852883 · DSI
Oxford Medilog, Inc.
Cardiovascular · 17d
Cleared Jul 26, 1985
MEDILOG M1
K852884 · DSI
Oxford Medilog, Inc.
Cardiovascular · 17d
Cleared Jul 26, 1985
SPINAL FIXATION INSTRUMENTATION SYSTEM
K852891
Buckman Co., Inc.
General & Plastic Surgery · 17d
Cleared Jul 26, 1985
ESTERIPAPEL BAGS
K852904
Sophlaril Hispania, S. A.
General & Plastic Surgery · 17d
Cleared Jul 26, 1985
THE IVY POLE-INTRAVENOUS BOT TREES #1121K & 1221K
K852937 · FOX
Northern Customfab, Inc.
General Hospital · 16d
Cleared Jul 26, 1985
WINGED INFUSION SETS
K852989 · FPA
An-Med Intl.
General Hospital · 11d
Cleared Jul 25, 1985
MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER
K850898 · DRS
Medi-Trace Products Division
Cardiovascular · 143d
Cleared Jul 25, 1985
TUBULITEC LINER
K851053 · EJK
Dental Therapeutics AB
Dental · 133d
Cleared Jul 25, 1985
SAVARY-GILLIARD DILATOR
K851955 · KNQ
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 25, 1985
ROTATABLE POLYPECTOMY SNARE POS-1
K851958 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 25, 1985
FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40
K852251 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 25, 1985
MODEL SA3 ESOPHAGEAL PH ELECTRODE
K852289 · FFT
World Precision Instruments, Inc.
Gastroenterology & Urology · 57d
Cleared Jul 25, 1985
HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.
K852464 · HQF
Hcg, Inc.
Ophthalmic · 45d
Cleared Jul 25, 1985
ETCH AND BOND
K852660 · KLE
Dentsply Intl.
Dental · 31d
Cleared Jul 25, 1985
ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251
K853017 · DXY
Ela Medical, Inc.
Cardiovascular · 8d
Cleared Jul 25, 1985
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
K853034 · DXY
Intermedics, Inc.
Cardiovascular · 7d
Cleared Jul 24, 1985
HIGH PRESSURE FLEX. CONNECTING TUBING
K841092 · DXT
Tronomed, Inc.
Cardiovascular · 498d
Cleared Jul 24, 1985
HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA
K844484 · KRG
Vitatron Medical BV
Cardiovascular · 247d
Cleared Jul 24, 1985
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · KNX
C.R. Bard, Inc.
Gastroenterology & Urology · 225d
Cleared Jul 24, 1985
COACH TM- THE AEROBIC FITNESS MONITOR
K851335 · DRT
Biotechnology, Inc.
Cardiovascular · 112d
Cleared Jul 24, 1985
ECG MONITOR MODEL RM102
K851496 · DXJ
Honeywell, Inc.
Cardiovascular · 100d
Cleared Jul 24, 1985
DISPOSABLE PLASTIC SYRINGES
K851523 · FMF
Transcoject GmbH & Co. KG
General Hospital · 99d