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
160297–160320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1982
MINI-MICRO ARTHROSCOPIC SCAPEL
K820777 · HRX
The Anspach Effort, Inc.
Orthopedic · 50d
Cleared May 12, 1982
CURITY PREMIUM CYSTOSCOPY TRAY
K820850 · KKX
The Kendal Co.
General Hospital · 47d
Cleared May 12, 1982
HI-PHORE HIGH RESOLUTION ELECTROPHORES
K821303 · JJN
Gelman Sciences, Inc.
Chemistry · 8d
Cleared May 11, 1982
CURITY ECONOMY I CYSTOSCOPY
K820838 · KOD
The Kendal Co.
Gastroenterology & Urology · 46d
Cleared May 10, 1982
RESILIENT GUM EXERCISER
K820979 · JET
Martin A. Hass, D.D.S.
Dental · 34d
Cleared May 10, 1982
PRECIOUS METAL ALLOYS
K821022 · EJS
J. Aderer, Inc.
Dental · 27d
Cleared May 10, 1982
BLINK-N-CLEAN
K821055 · HPX
Allergan, Inc.
Ophthalmic · 25d
Cleared May 10, 1982
ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG
K821079 · KLX
Ms. Kate Teaney
Ear, Nose, Throat · 21d
Cleared May 10, 1982
PEDIATRIC URINE COLLECTOR
K821130
Abco Dealers, Inc.
Gastroenterology & Urology · 20d
Cleared May 10, 1982
TS-180 SERIES TUBING SET
K821138 · FJK
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 19d
Cleared May 10, 1982
SPS-SINGLE PATIENT SYSTEM
K821139 · FIR
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 19d
Cleared May 10, 1982
EXTERNAL URINARY MALE INCONTINENCE DEV
K821161 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
URINARY COLLECTION CONTAINER/LEG BAG
K821171 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
EXTERNAL FEMALE URINARY INCONTINENCE
K821172 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
VIVONEX TUNGSTEN TIP TUBE PLACEMENT
K821231 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 13d
Cleared May 10, 1982
TECHNICON RA-1000 SYS, ANALYTES III
K821514 · JEJ
Technicon Instruments Corp.
Chemistry
Cleared May 07, 1982
MULTI-UNIT, MULTI-PURPOSE DEVICE
K813638 · EFS
The Scott & Fetzer Co.
Dental · 128d
Cleared May 07, 1982
INTRA-ARTICULAR SURGICAL SYSTEM
K820367 · KIJ
Dyonics, Inc.
Orthopedic · 87d
Cleared May 07, 1982
OTE BIOMEDICA BERG FOURIER ANALYZER
K820653 · OLT
Del Mar Avionics
Neurology · 59d
Cleared May 07, 1982
SEPCOR UNIT COLLECTION MONITOR
K820712 · KSQ
Separation Science Corp.
Hematology · 53d
Cleared May 07, 1982
AUTOSTIK
K820875 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 39d
Cleared May 07, 1982
PROGRAMMALITH II, #225 & 226
K821003 · DXY
Pacesetter Systems
Cardiovascular · 28d
Cleared May 07, 1982
PULSE GENERATOR
K821073 · DXY
Biotronik Sales, Inc.
Cardiovascular · 21d
Cleared May 07, 1982
IP SPECIFIC E
K821094 · DGO
Diagnostic Reagent Tech.
Immunology · 18d