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
113377–113400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1993
PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER +
K924279 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 269d
Cleared May 21, 1993
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
K924396 · GJT
Behring Diagnostics, Inc.
Hematology · 263d
Cleared May 21, 1993
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K924605 · LNH
General Electric Co.
Radiology · 252d
Cleared May 21, 1993
HARMONIC SCALPEL 5MM LAPAROSONIC BLADE ACCESSORY
K924917 · GEI
Ultracision, Inc.
General & Plastic Surgery · 234d
Cleared May 21, 1993
L-CATH PEEL-AWAY CATHETER SYSTEM
K924968 · FOZ
Luther Medical Products, Inc.
General Hospital · 233d
Cleared May 21, 1993
ORC TAPPERED IRRIGATING PROBE
K925024 · GCY
O.R. Concepts, Inc.
General & Plastic Surgery · 231d
Cleared May 21, 1993
TECHNOMED PULSOLITH 4000 LASER SYSTEM
K925395 · LNK
Teknomed, Inc.
General Hospital · 207d
Cleared May 21, 1993
SARNS RETROGRADE CANNULA
K925442 · DWF
3M Health Care, Sarns
Cardiovascular · 205d
Cleared May 21, 1993
BREATHING FILTERS 1942T/1941T/2014T
K925462 · CAH
Intersurgical, Inc.
General Hospital · 204d
Cleared May 21, 1993
COOK TISSUE MORCELLATOR
K925851 · GEI
Cook Urological, Inc.
General & Plastic Surgery · 185d
Cleared May 21, 1993
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
K925899 · DSK
Welch Allyn, Inc.
Cardiovascular · 182d
Cleared May 21, 1993
WALTHER CATHETERS, MALE, FEMALE
K926369 · GBM
Thomasville Medical Assoc.
Gastroenterology & Urology · 150d
Cleared May 21, 1993
HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
K926570 · KNX
Hollister, Inc.
Gastroenterology & Urology · 141d
Cleared May 21, 1993
PATPOS COMPACT
K930295 · IWE
Cp Bio-Medical Corp.
Radiology · 120d
Cleared May 21, 1993
PATPOS RED
K930296 · IWE
Cp Bio-Medical Corp.
Radiology · 120d
Cleared May 21, 1993
WIRE GUIDED OVAL DILATORS
K930465 · GCJ
Surgical Technologies, Inc.
General & Plastic Surgery · 113d
Cleared May 21, 1993
COMPRESSION CLAMP
K930466 · GCJ
Surgical Technologies, Inc.
General & Plastic Surgery · 113d
Cleared May 21, 1993
BABCOCK FORCEPS, GRASPING FORCEPS, NEEDLE HOLDER
K930467 · GCJ
Surgical Technologies, Inc.
General & Plastic Surgery · 113d
Cleared May 21, 1993
8-WATT PULSED DENTAL LASER SYSTEM
K930789 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 94d
Cleared May 21, 1993
2.5 WATT PULSED DENTAL LASER SYSTEM
K930879 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 91d
Cleared May 20, 1993
CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR
K910599 · DTW
Jtl Medical Corp.
Cardiovascular · 827d
Cleared May 20, 1993
PERIPHERAL INTERVENOUS CATHETER
K914378 · FOZ
Medical Profiles, Inc.
General Hospital · 597d
Cleared May 20, 1993
SHARPE ENDOTENACULUM
K915743 · HET
Paladin Medical, Inc.
Obstetrics & Gynecology · 514d
Cleared May 20, 1993
MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R)
K921706 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 405d