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
121393–121416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1991
SR1 ESTRADIOL ENZYME IMMUNOASSAY
K911396 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 60d
Cleared May 28, 1991
ABBOTT LIFECARE 5000 PUMP
K911401 · FRN
Abbott Laboratories
General Hospital · 60d
Cleared May 28, 1991
STAK-CHEX
K911582 · JCN
Streck Laboratories, Inc.
Hematology · 50d
Cleared May 28, 1991
MEDI GUARD PILLOWCASE
K911948 · KME
Sancella, Inc.
General Hospital · 27d
Cleared May 28, 1991
MEDI GUARD UNDERPAD
K911952 · KME
Sancella, Inc.
General Hospital · 27d
Cleared May 28, 1991
MEDI GUARD SHEETS/UNDERLAYS
K911953 · KME
Sancella, Inc.
General Hospital · 27d
Cleared May 28, 1991
WIDEX MODEL QX IN-THE-EAR HEARING AID
K912169 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 12d
Cleared May 24, 1991
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
K910805 · HQF
Heraeus Lasersonics, Inc.
Ophthalmic · 87d
Cleared May 24, 1991
SRI TSH IMMUNENZYMETRIC ASSAY
K910837 · JLW
Serono-Baker Diagnostics, Inc.
Chemistry · 86d
Cleared May 23, 1991
CARDIOCAP II TM CH-RESP MONITORS
K904355 · DPS
Instrumentarium Corp.
Cardiovascular · 241d
Cleared May 23, 1991
MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
K904870 · KXA
Endotec, Inc.
Orthopedic · 212d
Cleared May 23, 1991
ALDETECT
K905779 · FJI
Pochemco, Inc.
Gastroenterology & Urology · 147d
Cleared May 23, 1991
P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL
K910563 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 104d
Cleared May 23, 1991
ONE STEP BUTTON(TM)
K910584 · KGC
Applied Medical Technologies
Gastroenterology & Urology · 101d
Cleared May 23, 1991
TL100W/01 UVB LAMP
K910767 · FTC
Philips Lighting Co.
General & Plastic Surgery · 90d
Cleared May 23, 1991
SMALL INSTRUMENT STERILIZATION/BUR BOX
K910794 · EJL
Brevet, Inc.
Dental · 87d
Cleared May 23, 1991
STRYKER ARTHROSCOPIC INFUSION PUMP
K910858 · HRX
Stryker Corp.
Orthopedic · 84d
Cleared May 23, 1991
HOWMEDICA(R) CEMETED FEMORAL COMPONENT
K910869 · JDI
Howmedica Corp.
Orthopedic · 83d
Cleared May 23, 1991
ABBOTT LIFECARE 5000 PUMP MODIFIED
K910919 · FRN
Abbott Laboratories
General Hospital · 79d
Cleared May 23, 1991
PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM
K911197 · JWH
Orthomet, Inc.
Orthopedic · 66d
Cleared May 23, 1991
TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY
K911198 · JWH
Orthomet, Inc.
Orthopedic · 66d
Cleared May 23, 1991
LM-150HT LIGHT SOURCE
K911212 · ESI
Leisegang Medical, Inc.
Ear, Nose, Throat · 65d
Cleared May 23, 1991
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE
K911438 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 51d
Cleared May 23, 1991
INNOFLUOR VALPROIC ACID CALIBRATOR SET
K911466 · DLJ
Intl. Bioclinical, Inc.
Chemistry · 50d