FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
106369–106392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1994
DOCUMENT R AMMONIA/ETHANOL CONTROL
K944361 · JJX
Casco Standards
Chemistry · 84d
Cleared Nov 30, 1994
ORION ALL SILICONE ELASTOMER COATED CATHETER
K944376 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 30, 1994
ORION FOLEY CATHETER
K944380 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 30, 1994
ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
K944381 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 30, 1994
CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS
K944606 · DJG
Beckman-Diagnostic Systems Group
Toxicology · 72d
Cleared Nov 30, 1994
MILL-ROSE HARRELL BRONCHIAL BRUSH
K944649 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 70d
Cleared Nov 30, 1994
PULPDENT CALCIUM HYDROXIDE PREPARATIONS
K944945 · EJK
Pulpdent Corp.
Dental · 54d
Cleared Nov 30, 1994
URO - ELITE TABLE ACCESSORIES
K944987 · IXR
Philips Medical Systems (Cleveland),...
Radiology · 49d
Cleared Nov 30, 1994
INSTRUMENT,FILLING,PLASTIC,DENTAL
K945077 · EKJ
Worldwide Dental, Inc.
Dental · 44d
Cleared Nov 30, 1994
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
K945200 · KOO
Procter & Gamble Co.
Dental · 36d
Cleared Nov 29, 1994
WILSON-COOK BALLOON INFLATION DEVICE
K933845 · KNQ
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 480d
Cleared Nov 29, 1994
ADVANCE ANALYSIS SOFTWARE
K941223 · KPS
General Electric Co.
Radiology · 260d
Cleared Nov 29, 1994
SAFELINE SYSTEM TURN LOCK CANNULA
K941244 · FPA
Mcgaw, Inc.
General Hospital · 259d
Cleared Nov 29, 1994
BLOOD PRESSURE METER MODEL NO. BPM888
K941490 · DXN
Integrated Display Technology, Ltd.
Cardiovascular · 246d
Cleared Nov 29, 1994
MINIMUS I
K942649 · DXN
Rud Riester GmbH & CO KG
Cardiovascular · 182d
Cleared Nov 29, 1994
HEAD AND NECK COIL FOR THE GYREX 2T-DLX
K943320 · LNH
Elscint, Inc.
Radiology · 141d
Cleared Nov 29, 1994
DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM
K944162 · EAG
Teledyne Water Pik
Radiology · 95d
Cleared Nov 29, 1994
HI-Q HAND INSTRUMENTS- UROLOGY
K944201 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 92d
Cleared Nov 29, 1994
METAL-LINED TRANSCEND CERAMIC BRACKET
K944286 · DYW
Unitek Corp.
Dental · 88d
Cleared Nov 29, 1994
LIFE
K944416 · EJK
Sybron Dental Specialties, Inc.
Dental · 78d
Cleared Nov 29, 1994
CARRASYN FDG
K944427 · MGQ
Carrington Laboratories, Inc.
General & Plastic Surgery · 78d
Cleared Nov 29, 1994
KERLIX ZINC SALINE DRESSING
K944468 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 81d
Cleared Nov 29, 1994
PRIMA, INC. ADULT ANESTHESIA CIRCUIT
K944533 · CAI
Prima, Inc.
Anesthesiology · 75d
Cleared Nov 29, 1994
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
K944534 · BZA
Prima, Inc.
Anesthesiology · 75d