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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161185–161208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1982
TUBULAR STOCKINETTE
K820142 · FQM
Stan-Pak Ent.
General Hospital · 17d
Cleared Feb 05, 1982
STERI-SHURE
K820147 · JOJ
General Health Systems, Inc.
General Hospital · 17d
Cleared Feb 05, 1982
PYR BROTH
K820149 · JSF
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 17d
Cleared Feb 05, 1982
TDX DIGOXIN
K820154 · LCS
Abbott Laboratories
Toxicology · 17d
Cleared Feb 05, 1982
OLSEN #770 DISPOSABLE HOLSTER
K820158 · KDC
Olsen Electro-Surgical Instruments, Inc.
General & Plastic Surgery · 16d
Cleared Feb 05, 1982
MALE LUER CONNECTOR & HINGED CAP
K820169 · FJK
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 15d
Cleared Feb 05, 1982
MED-CARE EMERGENCY SHEARS
K820170 · FZT
Medcare Products
General & Plastic Surgery · 15d
Cleared Feb 05, 1982
VYGON ENTERNAL NUTRITION TUBES
K820176 · KNT
Exco, Inc.
Gastroenterology & Urology · 14d
Cleared Feb 05, 1982
COAGULASE PLASMA
K820177 · JTL
Quadroma, Inc.
Microbiology · 14d
Cleared Feb 05, 1982
CALCULI FILTER CUP
K820180 · FMH
Omnimedical
General Hospital · 14d
Cleared Feb 05, 1982
PHENOBARBITAL ASSAY
K820188 · LET
Syva Co.
Toxicology · 11d
Cleared Feb 05, 1982
FLUID ADMINISTRATIVE SET, AFI
K820203 · FPA
Linton Biomed Corp.
General Hospital · 10d
Cleared Feb 05, 1982
VP I
K820204 · JTO
Dms Laboratories
Microbiology · 10d
Cleared Feb 05, 1982
VP 2
K820205 · JTO
Dms Laboratories
Microbiology · 10d
Cleared Feb 05, 1982
NIT 1
K820206 · JTO
Dms Laboratories
Microbiology · 10d
Cleared Feb 05, 1982
NIT 2
K820207 · JTO
Dms Laboratories
Microbiology · 10d
Cleared Feb 05, 1982
ZYME A
K820208
Dms Laboratories
Microbiology · 10d
Cleared Feb 05, 1982
SUCROSE
K820214 · JSE
Dms Laboratories
Microbiology · 10d
Cleared Feb 05, 1982
OMS QUARTZ INFUSION CONTACT LENS
K820223 · HJI
Optical Micro Systems, Inc.
Ophthalmic · 9d
Cleared Feb 04, 1982
CAPILLARY PERFUSION MONITOR #LD5000
K812005 · DPW
Nuclear Pacific, Inc.
Cardiovascular · 205d
Cleared Feb 04, 1982
PERMANENT ENDOCARD. UNIPOLAR TINED LEAD
K812905 · DTB
Diag Corp.
Cardiovascular · 108d
Cleared Feb 04, 1982
ULTRACAST WATERLESS SYNTHETIC RESIN CAST
K813052 · ITG
Zimmer, Inc.
Physical Medicine · 98d
Cleared Feb 04, 1982
JET VENTILATOR
K813254 · CBK
Healthdyne, Inc.
Anesthesiology · 77d
Cleared Feb 04, 1982
MULTIPLE BANDAGE OR DRESSING
K813365 · FRO
Cederroth, Inc. USA
General & Plastic Surgery · 66d