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
109921–109944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1994
WINDMERE WAND MASSAGER
K932904 · ISA
Windmere Corp.
Physical Medicine · 246d
Cleared Feb 17, 1994
BATTERY PACK# S1009LA
K933065 · DPS
Portable Power Systems, Inc.
Cardiovascular · 240d
Cleared Feb 17, 1994
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K933112 · HRS
Alphatec Mfg., Inc.
Orthopedic · 237d
Cleared Feb 17, 1994
REFRACTOMETRIC, TOTAL PROTEIN
K933218 · JJX
Pyramid Biological Corp.
Chemistry · 231d
Cleared Feb 17, 1994
STOOL TRANSPORT/PROCESSOR
K933370 · LKS
Sage Products, Inc.
Microbiology · 223d
Cleared Feb 17, 1994
RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB
K934015 · LDD
Portable Power Systems, Inc.
Cardiovascular · 184d
Cleared Feb 17, 1994
STERILE DRESSING CHANGE TRAY
K934028 · LRO
Surgipro, Inc.
General Hospital · 184d
Cleared Feb 17, 1994
RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR
K934439 · DPS
Portable Power Systems, Inc.
Cardiovascular · 178d
Cleared Feb 17, 1994
BATTERY PACK# S1024NC
K934508 · LDD
Portable Power Systems, Inc.
Cardiovascular · 156d
Cleared Feb 17, 1994
5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD
K934510 · GCL
Phx Technologies Corp.
Gastroenterology & Urology · 156d
Cleared Feb 17, 1994
5,6,7,9,10,11&12MM BLUNT-TIPPED TROCAR OBTURATORS
K934511 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 156d
Cleared Feb 17, 1994
WHEEL-O-VATOR
K934553 · ING
The National Wheel-O-Vator Co., Inc.
Physical Medicine · 149d
Cleared Feb 17, 1994
CONMED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUNDING PADS
K934656 · GEI
Conmedcorp
General & Plastic Surgery · 142d
Cleared Feb 17, 1994
YANKAUER WITH CONNECTING TUBING
K934750 · GCJ
Trinity Laboratories, Inc.
General & Plastic Surgery · 136d
Cleared Feb 17, 1994
CONMED SELECTONE SURGICAL INSTRUMENTS
K934800 · GEI
Conmedcorp
General & Plastic Surgery · 133d
Cleared Feb 17, 1994
ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD
K934985 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 122d
Cleared Feb 17, 1994
AUTO SUTURE DISPOSABLE OPTICAL TROCAR
K935086 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 118d
Cleared Feb 17, 1994
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · MGQ
C.R. Bard, Inc.
General & Plastic Surgery · 118d
Cleared Feb 17, 1994
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · FRG
Sherwood Medical Co.
General Hospital · 108d
Cleared Feb 17, 1994
PARASAFE(R) FIXATIVE
K935316 · LKS
Scientific Device Laboratory, Inc.
Microbiology · 107d
Cleared Feb 17, 1994
VISUAL HEALTHSHIELDS
K935446 · HQY
Yorktowne Optical Co., Inc.
Ophthalmic · 97d
Cleared Feb 17, 1994
LOCALIZATION WIRE OR MARKER - SURGICAL
K935457 · GDF
Bip USA, Inc.
General & Plastic Surgery · 97d
Cleared Feb 17, 1994
CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER)
K935491 · HFX
Tri-State Hospital Supply Corp.
Obstetrics & Gynecology · 94d
Cleared Feb 17, 1994
MLT-2
K935981 · ILQ
Med Labs, Inc.
Physical Medicine · 65d