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
118057–118080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1992
MOSS - ANCHOR SET
K913701 · FPD
Moss Medical Products
Gastroenterology & Urology · 179d
Cleared Feb 14, 1992
CLINITRON C-10
K914351 · IXQ
Ssi Medical Services, Inc.
Radiology · 140d
Cleared Feb 14, 1992
SURGICAL APPAREL
K914832 · FXX
W.L. Gore & Associates, Inc.
General Hospital · 112d
Cleared Feb 14, 1992
GUIDER DASHER
K915115 · DQX
Target Therapeutics
Cardiovascular · 93d
Cleared Feb 14, 1992
7000 SERIES TOTAL KNEE PATELLAR COMPONENTS
K915186 · JWH
Osteonics Corp.
Orthopedic · 88d
Cleared Feb 14, 1992
7000 SERIES MODULAR TIBIAL COMPONENTS
K915192 · JWH
Osteonics Corp.
Orthopedic · 87d
Cleared Feb 14, 1992
ENZYMUN-TEST TSH
K915195 · JLW
Boehringer Mannheim Corp.
Chemistry · 87d
Cleared Feb 14, 1992
DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP
K915207 · EEF
Bay Technical Products, Inc.
Dental · 88d
Cleared Feb 14, 1992
AAP BONE SCREW
K915316 · HWC
Aap International, Ltd.
Orthopedic · 84d
Cleared Feb 14, 1992
EBV-VCA IGM ELISA
K915348 · LJN
Pharmacia Diagnostics, Inc.
Microbiology · 80d
Cleared Feb 14, 1992
CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER
K915374 · DQY
Cordis Corp.
Cardiovascular · 77d
Cleared Feb 14, 1992
ELLAGIC ACID APTT REAGENT
K915418 · GFO
Helena Laboratories
Hematology · 74d
Cleared Feb 14, 1992
ANESTHESIA BREATHING CIRCUIT
K915452 · CAI
Concord/Portex
Anesthesiology · 71d
Cleared Feb 14, 1992
GYREX 2T-DLX
K915601 · LNH
Elscint, Inc.
Radiology · 63d
Cleared Feb 14, 1992
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE
K915623 · JAK
Shimadzu Medical Systems
Radiology · 60d
Cleared Feb 14, 1992
MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG
K915760 · DPS
Corazonic Corp.
Cardiovascular · 53d
Cleared Feb 14, 1992
CMV IGG ELISA TEST
K915892 · LFZ
Gull Laboratories, Inc.
Microbiology · 52d
Cleared Feb 14, 1992
AFFINITY B12
K920078 · CDD
Bd Becton Dickinson Vacutainer...
Chemistry · 37d
Cleared Feb 14, 1992
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT
K920253 · JHI
Medix Biotech, Inc.
Chemistry · 24d
Cleared Feb 14, 1992
RIONET HEARING AID HB-53P
K920486 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 15d
Cleared Feb 13, 1992
SINGLE USE LEE ELECTRODE
K913213 · HGI
Aspen Laboratories, Inc.
Obstetrics & Gynecology · 209d
Cleared Feb 13, 1992
BONE SCREW 3.5 MM
K915613 · HWC
Acu Med, Inc.
Orthopedic · 59d
Cleared Feb 12, 1992
POWER TRAINER WITH NEUROMUSCULAR STIMULATION
K904509 · IPF
Sinties Scientific, Inc.
Physical Medicine · 498d
Cleared Feb 12, 1992
REGENCY, COMPARE, SUN OPTICS SUNGLASSES
K913419 · HQY
Cliff Weil, Inc.
Ophthalmic · 196d