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
98953–98976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1996
SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
K953634 · IYO
Shimadzu Medical Systems
Radiology · 195d
Cleared Feb 13, 1996
ROCHE REAGENT FOR GLUCOSE
K953847 · CFR
Roche Diagnostic Systems, Inc.
Chemistry · 181d
Cleared Feb 13, 1996
OMNI COLD GEL PACKS
K954877 · IMD
Omni Therm, Inc.
Physical Medicine · 112d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 1 COMPLEX
K955222 · GRM
Sa Scientific, Inc.
Microbiology · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 1 ANTISERUM
K955223 · GNC
Sa Scientific, Inc.
Microbiology · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 2 ANTISERUM
K955224 · GNC
Sa Scientific, Inc.
Microbiology · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 3 ANTISERUM
K955225 · GNC
Sa Scientific, Inc.
Microbiology · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 4 ANTISERUM
K955226 · GNC
Sa Scientific, Inc.
Microbiology · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS EN COMPLEX ANTISERUM
K955227 · GNC
Sa Scientific, Inc.
Microbiology · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS L COMPLEX
K955228 · GNC
Sa Scientific, Inc.
Microbiology · 91d
Cleared Feb 13, 1996
DYNAMEQ-II OPTION
K955466 · ESD
Qualitone
Ear, Nose, Throat · 75d
Cleared Feb 13, 1996
NEO-PNEUMOCATH
K955474 · GBX
Intra Special Catheters GmbH
General & Plastic Surgery · 75d
Cleared Feb 13, 1996
OLYMPUS BIPOLAR FORCEPS
K955623 · GEI
Olympus America, Inc.
General & Plastic Surgery · 64d
Cleared Feb 13, 1996
LASERSONICS PARASCAN DOSIMETER DEVICE
K955734 · GEX
Heraeus Surgical, Inc.
General & Plastic Surgery · 57d
Cleared Feb 13, 1996
MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM
K960013 · FOZ
MDC Research , Ltd.
General Hospital · 42d
Cleared Feb 13, 1996
CARDON PHYSICAL THERAPY TABLE MODEL R28598
K960332 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 20d
Cleared Feb 13, 1996
CARDON PHYSICAL THERAPY TABLE MODEL R27116
K960334 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 20d
Cleared Feb 13, 1996
CARDON PHYSICAL THERAPY TABLE MODEL R27645
K960336 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 20d
Cleared Feb 12, 1996
EURO SC500
K944940 · INI
Pride Health Care, Inc.
Physical Medicine · 493d
Cleared Feb 12, 1996
SURGIFLATOR 20
K950035 · HIF
W.O.M. GmbH
Obstetrics & Gynecology · 404d
Cleared Feb 12, 1996
OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
K952892 · ITX
Olympus America, Inc.
Radiology · 234d
Cleared Feb 12, 1996
A-V IMPULSE SYSTEM MODEL 6060
K953648 · JOW
Novamedix , Ltd.
Cardiovascular · 192d
Cleared Feb 12, 1996
MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)
K954284 · DTL
Medi-Plast Intl., Inc.
Cardiovascular · 166d
Cleared Feb 12, 1996
NON APPLICATOR TAMPON, UNTREATED
K954445 · HEB
Hygieia Healthcare , Ltd.
Obstetrics & Gynecology · 140d