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
131881–131904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1989
MICRO SURGERY SCISSORS
K891040 · KNA
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d
Cleared Mar 17, 1989
MICRO SURGERY NEEDLE HOLDERS
K891042 · KNA
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d
Cleared Mar 17, 1989
LASER SPECULA
K891044 · HDF
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d
Cleared Mar 17, 1989
ZEPPELIN FORCEPS
K891047 · HCZ
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d
Cleared Mar 17, 1989
ZEPPELIN SCISSORS
K891049 · KOH
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d
Cleared Mar 17, 1989
MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE
K891088 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 71d
Cleared Mar 17, 1989
MICROLASE CO2 LASER MICROMANIPULATOR
K891126 · GEX
Ximed Medical Systems
General & Plastic Surgery · 14d
Cleared Mar 16, 1989
RECONDITIONED ASTRA (TM) 8
K883298 · JJF
Associated Electro-Medical Services,...
Chemistry · 224d
Cleared Mar 16, 1989
RECONDITIONED ASTRA(TM) 4
K883350 · JJF
Associated Electro-Medical Services,...
Chemistry · 219d
Cleared Mar 16, 1989
506 NON-INVASIVE VITAL SIGNS MONITOR
K884216 · DSI
Criticare Systems, Inc.
Cardiovascular · 161d
Cleared Mar 16, 1989
RESUBMITTED SCANORA
K884650 · IZF
Orion Corp.
Radiology · 129d
Cleared Mar 16, 1989
BIOSONIC ULTRASONIC CLEANING SYSTEM
K884660 · FLG
Whaledent Intl. Div. Ipco
General Hospital · 129d
Cleared Mar 16, 1989
ACS SELECTIVE INFUSION CATHETER
K885237 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Mar 16, 1989
EPIDURAL ANESTHESIA TRAY
K885278 · CAZ
Preferred Medical Products
Anesthesiology · 83d
Cleared Mar 16, 1989
SANI-SLEEVE DRAPE FOR DENTAL USE
K885299 · EIA
Nieusma R & D, Inc.
Dental · 79d
Cleared Mar 16, 1989
ELECTRONIC DIGITAL THERMOMETER
K885308 · FLL
Ewig Industries Co. , Ltd.
General Hospital · 79d
Cleared Mar 16, 1989
FEMORAL ANGIOGRAPHY DRAPE
K890101 · KKX
Medical Plastics, Inc.
General Hospital · 65d
Cleared Mar 16, 1989
CYTEX ONE AND CYTEX TWO
K890283 · HHT
Anderson Winn Paper Co.
Obstetrics & Gynecology · 56d
Cleared Mar 16, 1989
NICOLET VIKING II SYSTEM
K890495 · IKN
Nicolet Instrument Corp.
Neurology · 43d
Cleared Mar 16, 1989
TSH MICROASSAY
K890579 · JLW
Diamedix Corp.
Chemistry · 38d
Cleared Mar 16, 1989
STUART TITANIUM SURGICAL MESH
K890601 · EZX
Stuart
General & Plastic Surgery · 38d
Cleared Mar 16, 1989
EMPI ISLAND TENS ELECTRODE
K890605 · GXY
Empi
Neurology · 38d
Cleared Mar 16, 1989
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
K890609 · CGS
Intl. Immunoassay Laboratories, Inc.
Chemistry · 37d
Cleared Mar 16, 1989
EMPI MULTIDAY TENS DISPOSABLE ELECTRODE
K890614 · GXY
Empi
Neurology · 37d