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
106201–106224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1994
PROTECTAIDE CPR PROTECTION PACK NO. 17701
K942466 · CBP
Protectaide, Inc.
Anesthesiology · 134d
Cleared Oct 06, 1994
PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000
K942467 · CBP
Protectaide, Inc.
Anesthesiology · 134d
Cleared Oct 06, 1994
ACE CEDIA PHENOBARBITAL ASSAY
K942501 · DLZ
Schiapparelli Biosystems, Inc.
Chemistry · 135d
Cleared Oct 06, 1994
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
K942551 · DIF
Medi-Tech, Inc.
Toxicology · 128d
Cleared Oct 05, 1994
SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE
K931914 · GAR
Surgimetrics International, Ltd.
General & Plastic Surgery · 537d
Cleared Oct 05, 1994
ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT
K940235 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 260d
Cleared Oct 05, 1994
MOUTH PROPS
K940785 · EIF
Worldwide Dental, Inc.
Dental · 225d
Cleared Oct 05, 1994
URETERAL ILLUMINATOR
K941506 · FCS
Apple Medical Corp.
Gastroenterology & Urology · 190d
Cleared Oct 05, 1994
OPTION SHELL
K942406 · JDI
Intermedics Orthopedics
Orthopedic · 138d
Cleared Oct 05, 1994
OSTEOGRAF/D-100 HYDROXYLAPATITE
K942946 · LYC
Ceramed Corp.
Dental · 104d
Cleared Oct 05, 1994
HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT
K943334 · DZC
Jay H. Geller
Dental · 85d
Cleared Oct 05, 1994
AVENT NIPPLE SHIELD
K944117 · HFS
Avent America, Inc.
General Hospital · 43d
Cleared Oct 05, 1994
BREAST SHELL
K944177 · HFS
O'Donnell, Byrne & Williams
General Hospital · 40d
Cleared Oct 05, 1994
GSI KNOTMAKER
K944536 · GCJ
General Surgical Innovations
General & Plastic Surgery · 20d
Cleared Oct 04, 1994
PINNACLE 3
K926008 · IYE
Adac Laboratories
Radiology · 676d
Cleared Oct 04, 1994
NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE
K932059 · IKT
Dantec Medical, Inc.
Neurology · 523d
Cleared Oct 04, 1994
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
K934132 · CAH
Porous Media Corp.
General Hospital · 405d
Cleared Oct 04, 1994
MULTI ANALYTE LINEARITY SET
K936245 · JJY
Teco Diagnostics
Chemistry · 278d
Cleared Oct 04, 1994
SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM
K940913 · HRX
Spine-Tech, Inc.
Orthopedic · 221d
Cleared Oct 04, 1994
THE WUSCOPE SYSTEM
K941319 · CCW
Achi Corp.
Anesthesiology · 200d
Cleared Oct 04, 1994
ULTATHIN FLEXIBLE ENDOSCOPE
K941715 · LYK
Technology Marketing Group
Cardiovascular · 180d
Cleared Oct 04, 1994
PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE
K942046 · FPA
Pharmacia Deltec, Inc.
General Hospital · 159d
Cleared Oct 04, 1994
ROCHE AMMONIA (VARIOUS)
K942048 · DKB
Roche Diagnostic Systems, Inc.
Chemistry · 159d
Cleared Oct 04, 1994
APR II FEMORAL COMPONENT (VARIOUS)
K942330 · LZO
Intermedics Orthopedics
Orthopedic · 141d