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
117217–117240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1992
LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE
K921656 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 31d
Cleared May 07, 1992
IMX INSULIN
K920109 · CFP
Abbott Laboratories
Chemistry · 118d
Cleared May 07, 1992
TRIAL LENS SET
K920571 · HPC
R.H. Burton Co.
Ophthalmic · 90d
Cleared May 07, 1992
KEMTROL SERUM CONTROL-ABNORMAL
K920926 · JJY
Helena Laboratories
Chemistry · 69d
Cleared May 07, 1992
SYNERMED ALT/GPT REAGENT KIT
K921016 · CKA
Synermed, Inc.
Chemistry · 65d
Cleared May 07, 1992
NOW PREGNANCY TEST KIT
K921211 · JHI
Bio Clinic Co.
Chemistry · 56d
Cleared May 07, 1992
MIRCO ELISA HPL TEST KIT
K921212 · JHI
Bio Clinic Co.
Chemistry · 56d
Cleared May 07, 1992
ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
K921488 · HMX
Surgical Technologies, Inc.
Ophthalmic · 38d
Cleared May 06, 1992
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · GAD
United States Surgical, A Division of...
General & Plastic Surgery · 231d
Cleared May 06, 1992
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
K914836 · CAF
Omron Healthcare, Inc.
Anesthesiology · 194d
Cleared May 06, 1992
VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS
K914991 · GEX
Coherent Medical Group
General & Plastic Surgery · 181d
Cleared May 06, 1992
STRETCH WRAP
K915446 · KGX
Sun Glitz Corp.
General & Plastic Surgery · 153d
Cleared May 06, 1992
CHOLANGIOGRAM CATHETER KIT
K920236 · FGE
Mccol Medical,Inc.
Gastroenterology & Urology · 110d
Cleared May 06, 1992
MANUAL SURGICAL INSTRUMENTS
K920263 · KDC
Phoenix Instruments Div.
General & Plastic Surgery · 106d
Cleared May 06, 1992
ULTRA-THIN
K920547 · LIT
Boston Scientific Corp
Cardiovascular · 90d
Cleared May 06, 1992
LAPAROSCOPIC SUCTION/IRRIGATION PROBE
K920643 · GBZ
O.R. Concepts, Inc.
General & Plastic Surgery · 84d
Cleared May 06, 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
K920711 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared May 06, 1992
KONICA LI 10 AND 10A LASER IMAGER
K920769 · LMC
Konica Corp.
Radiology · 90d
Cleared May 06, 1992
DOBBHOFF BIPOLAR ADAPTER
K921029 · KNS
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 64d
Cleared May 06, 1992
CHOLANGIOLAPCATH(TM)
K921091 · GBZ
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 61d
Cleared May 06, 1992
MAXAQUIN
K921282 · JTN
Difco Laboratories, Inc.
Microbiology · 50d
Cleared May 06, 1992
M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)
K921472 · JSM
Microtest
Microbiology · 48d
Cleared May 06, 1992
BRINK PRE-MAXILLARY IMPLANT
K921580 · FZE
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared May 06, 1992
CHIN WAFER
K921581 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 34d