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
105409–105432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1994
DMA CALCIUM PLUS PROCEDURE
K944255 · CJY
Data Medical Associates, Inc.
Chemistry · 96d
Cleared Dec 06, 1994
ORION'S URINARY DRAINAGE SET
K944377 · KNX
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 06, 1994
ORION ALL SILICONE FOLEY CATHETER
K944382 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 06, 1994
ORION RED URETHRAL CATHETER
K944383 · EZD
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 06, 1994
INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES
K944672 · GCJ
Boston Scientific Corp
General & Plastic Surgery · 75d
Cleared Dec 05, 1994
GED (GRADUATED ELECTRONIC DECELERATOR
K911820 · HCB
Behavior Research Institute, Inc.
Neurology · 1321d
Cleared Dec 05, 1994
OVER THE GUIDEWIRE DILATATION SYSTEM
K924646 · KNQ
Medovations, Inc.
Gastroenterology & Urology · 812d
Cleared Dec 05, 1994
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · KHS
Boehringer Mannheim Corp.
Chemistry · 507d
Cleared Dec 05, 1994
R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050
K935301 · HGM
R & D Batteries, Inc.
Obstetrics & Gynecology · 397d
Cleared Dec 05, 1994
R AND D BATTERIES
K935377 · HGM
R & D Batteries, Inc.
Obstetrics & Gynecology · 392d
Cleared Dec 05, 1994
MODEL ACUITY CENTRAL STATION
K935846 · DSI
Protocol Systems, Inc.
Cardiovascular · 362d
Cleared Dec 05, 1994
SMARTBRACE ELECTRODE
K940012 · GXY
Medical Devices, Inc.
Neurology · 335d
Cleared Dec 05, 1994
WEBB-MORLEY SPINE SYSTEM
K941367 · KWQ
Electro-Biology, Inc.
Orthopedic · 259d
Cleared Dec 05, 1994
CORTICAL BONE SCREW
K942340 · HWC
Acu Med, Inc.
Orthopedic · 203d
Cleared Dec 05, 1994
CANNULATED CANCELLOUS BONE SCREW
K942341 · HWC
Acu Med, Inc.
Orthopedic · 203d
Cleared Dec 05, 1994
ACUFEX T-FIX DELIVERY SYSTEM
K942442 · MIA
Acufex Microsurgical, Inc.
Anesthesiology · 196d
Cleared Dec 05, 1994
ALTAIR-DISC RECORDER
K942565 · DQK
Burdick Corp.
Cardiovascular · 188d
Cleared Dec 05, 1994
CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER
K942704 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 180d
Cleared Dec 05, 1994
MAHE INSTRUMENTS
K942823 · DWG
Mahe Intl., Inc.
General & Plastic Surgery · 174d
Cleared Dec 05, 1994
CASSETTE SYSTEM FOR STORZ
K942945 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 166d
Cleared Dec 05, 1994
ELECTROFLEX
K943126 · GXY
Medical Devices, Inc.
Neurology · 159d
Cleared Dec 05, 1994
SURGIDEK
K943216 · GAR
Sutures , Ltd.
General & Plastic Surgery · 153d
Cleared Dec 05, 1994
PLAIN CATGUT
K943217 · GAL
Sutures , Ltd.
General & Plastic Surgery · 153d
Cleared Dec 05, 1994
CHROMIC CATGUT
K943218 · GAL
Sutures , Ltd.
General & Plastic Surgery · 153d