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
97177–97200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1996
DURACON ALL POLYETHYLENE PATELLA II
K961483 · JWH
Howmedica Corp.
Orthopedic · 82d
Cleared Jul 09, 1996
EG-2940, VIDEO GASTROSCOPE
K961564 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 77d
Cleared Jul 09, 1996
ED-344OT
K961568 · FDT
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 77d
Cleared Jul 09, 1996
APR FULLY TEXTURED HIP STEM
K961589 · LZO
Intermedics Orthopedics
Orthopedic · 76d
Cleared Jul 09, 1996
PURITAN FOAM TIP SWAB MODEL 2197
K961934 · HHT
Hardwood Products Co., LP
Obstetrics & Gynecology · 53d
Cleared Jul 09, 1996
S-57 VIDEO IMAGING SYSTEM
K962024 · FET
Del Medical Systems Corp.
Gastroenterology & Urology · 47d
Cleared Jul 09, 1996
DEXTERITY PNEUMO SLEEVE SET
K962147 · GCJ
Medical Creative Technologies, Inc.
General & Plastic Surgery · 36d
Cleared Jul 08, 1996
MCCOY CELL CULTURES
K955608 · KIR
Vai Diagnostics, Inc.
Microbiology · 213d
Cleared Jul 08, 1996
SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K955743 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 203d
Cleared Jul 08, 1996
CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
K955772 · FMI
Ttk Biomed, Ltd.
General Hospital · 200d
Cleared Jul 08, 1996
CDM
K960392 · LDM
Bio-Rad
Chemistry · 161d
Cleared Jul 08, 1996
CONTROL SYRINGE
K960882 · FMF
Louisville Laboratories, Inc.
General Hospital · 139d
Cleared Jul 08, 1996
EPIVIEW
K961319 · MGP
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 94d
Cleared Jul 08, 1996
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · LDP
Diagnostic Reagents, Inc.
Toxicology · 90d
Cleared Jul 08, 1996
VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM
K961434 · EBF
Vident
Dental · 84d
Cleared Jul 08, 1996
FUJI IX GP
K961448 · EMA
GC America, Inc.
Dental · 83d
Cleared Jul 08, 1996
HUMAN GROWTH HORMONE IMMUNOASSAY KIT
K961678 · CFL
Nichols Institute Diagnostics
Chemistry · 68d
Cleared Jul 08, 1996
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC...
K961703 · FRN
Baxter Healthcare Corp
General Hospital · 67d
Cleared Jul 08, 1996
UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
K962211 · KLI
United Biotech, Inc.
Chemistry · 28d
Cleared Jul 05, 1996
DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION
K951965 · DEH
Dako Corp.
Immunology · 435d
Cleared Jul 05, 1996
LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS
K955845 · GCJ
Surgical Image Laboratories, Inc.
General & Plastic Surgery · 196d
Cleared Jul 05, 1996
FLEXIBLE PHASED ARRAY SPINE COIL
K960497 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 154d
Cleared Jul 05, 1996
CHEK-STIX U.T.I. SELF-TEST
K960888 · JMT
Bayer Corp.
Chemistry · 123d
Cleared Jul 05, 1996
DTX-200 BONE DENSITOMETER
K961011 · KGI
Shotwell & Carr, Inc.
Radiology · 114d