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
91801–91824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1997
PERACT 20 LIQUID STERILANT
K960513 · MED
Minntech Corp.
General Hospital · 604d
Cleared Oct 01, 1997
LEIBINGER SELF-DRILLING SCREW
K970912 · HWC
Howmedica Leibinger, Inc.
Orthopedic · 203d
Cleared Oct 01, 1997
OXI-SNAP
K971184 · MNR
Snap Laboratories, LLC
Anesthesiology · 183d
Cleared Oct 01, 1997
DISTALLY FIXED HIP STEM
K971523 · MEH
Sulzer Orthopedics, Inc.
Orthopedic · 156d
Cleared Oct 01, 1997
COLORPOINT OR PROFESSIONAL COLORPOINT
K971760 · LMC
Seiko Instruments USA, Inc.
Radiology · 142d
Cleared Oct 01, 1997
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND...
K971935 · JBP
B & D Corp.
Hematology · 127d
Cleared Oct 01, 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · HWC
Depuy, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
APOLLO REVISION/CONSTRAINED KNEE SYSTEM
K972501 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 01, 1997
INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
K972506 · HJM
Infinitech, Inc.
Ophthalmic · 90d
Cleared Oct 01, 1997
NAVIGATOR (STYLET) 2006
K972521 · GAH
Sil-Med Corp.
General & Plastic Surgery · 86d
Cleared Oct 01, 1997
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 86d
Cleared Oct 01, 1997
HEARTPORT INTRODUCER SHEATH
K972570 · DYB
Heartport, Inc.
Cardiovascular · 83d
Cleared Oct 01, 1997
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
K972578 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 83d
Cleared Oct 01, 1997
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE...
K972579 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Oct 01, 1997
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584 · ERL
Stryker Endoscopy
Ear, Nose, Throat · 83d
Cleared Oct 01, 1997
PMT NEW BEGINNINGS GELSHAPES & AMEND
K972597 · MDA
Pmt Corp.
General & Plastic Surgery · 82d
Cleared Oct 01, 1997
HELAX-VISIR
K972617 · IYE
Helax AB
Radiology · 84d
Cleared Oct 01, 1997
ULTRACELL SUCTION SPONGE
K972635 · GBX
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 79d
Cleared Oct 01, 1997
PRECEDENT REVISION HIP SYSTEM
K972637 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 78d
Cleared Oct 01, 1997
CRYOGEN CRYOSURGICAL SYSTEM
K972662 · GEH
Cryogen, Inc.
General & Plastic Surgery · 90d
Cleared Oct 01, 1997
ORIGIN LIGATOR DEVICE
K972685 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 76d
Cleared Oct 01, 1997
REDYROB-CLOSED WOUND DRAINAGE SYSTEM
K972703 · GCY
B.Braun Medical, Inc.
General & Plastic Surgery · 75d
Cleared Oct 01, 1997
CORE RESISTANT HUBER INFUSION SETS
K972712 · FPA
Icu Medical, Inc.
General Hospital · 72d
Cleared Oct 01, 1997
M-2 ANTERIOR PLATE SYSTEM
K972718 · KWQ
Acromed Corp.
Orthopedic · 72d