FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85561–85584 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1999
ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
K991870 · CGZ
A.P. Total Care, Inc.
Chemistry · 59d
Cleared Jul 30, 1999
EMS SURFACE MOUNT SCALER
K991874 · ELC
(Ems Sa) Electro Medical Systems
Dental · 58d
Cleared Jul 30, 1999
DERMAPHYLYX FOAM ISLAND DRESSING
K991933 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 52d
Cleared Jul 30, 1999
ULTRASOUND SCANNER, MODEL TYPE 2101
K991937 · IYO
B & K Medical A/S
Radiology · 51d
Cleared Jul 30, 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · MDA
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Jul 30, 1999
LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K992018 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 44d
Cleared Jul 30, 1999
MAMEX
K992037 · IZH
Del Medical Imaging Corp.
Radiology · 44d
Cleared Jul 30, 1999
PULSTAR
K992061 · GEX
Lasermed, Inc.
General & Plastic Surgery · 42d
Cleared Jul 30, 1999
SCARAID SILICONE GEL SHEETING
K992146 · MDA
Biodermis Corp.
General & Plastic Surgery · 36d
Cleared Jul 30, 1999
QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT
K992186 · GEI
Conmedcorp
General & Plastic Surgery · 31d
Cleared Jul 30, 1999
DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL...
K992218 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 29d
Cleared Jul 30, 1999
POWDERED LATEX STERILE SURGICAL GLOVES
K992219 · KGO
Tg Medical Sdn. Bhd.
General Hospital · 29d
Cleared Jul 30, 1999
CRIT-LINE MONITOR III (CLM III)
K992227 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 28d
Cleared Jul 30, 1999
STAPLETAC BONE ANCHOR SYSTEM
K992277 · HWC
Influence, Inc.
Orthopedic · 23d
Cleared Jul 30, 1999
AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE
K992288 · GCJ
Tyco Intl. (Us), Inc.
General & Plastic Surgery · 23d
Cleared Jul 30, 1999
OSTEONICS ACCP SYSTEM LINE EXTENSION
K992344 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Jul 30, 1999
BLUNT TIP TROCAR PORT
K992353 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 16d
Cleared Jul 30, 1999
ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS,...
K992408 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 10d
Cleared Jul 29, 1999
BICORTICAL SCREW
K983120 · DZE
Oraltronics Marketing-Und Vertriebs GmbH
Dental · 328d
Cleared Jul 29, 1999
SD-100 SKYEAR THERMOMETER
K984506 · FLL
Skylark Device Co., Ltd.
General Hospital · 223d
Cleared Jul 29, 1999
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
K991512 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Jul 29, 1999
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
K991533 · FGE
Peripheral Ave
Gastroenterology & Urology · 87d
Cleared Jul 29, 1999
BIOTHANE PATIENT RESTRAINT
K991591 · FMQ
Bioplastics
General Hospital · 83d
Cleared Jul 29, 1999
UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES
K991659 · GEX
Medart Corp.
General & Plastic Surgery · 76d