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
127657–127680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1990
VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE
K895993 · KMK
Vitaphore Corp.
General Hospital · 90d
Cleared Jan 11, 1990
PHOSPHORUS
K895999 · CEO
American Monitor Corp.
Chemistry · 90d
Cleared Jan 11, 1990
ASPARTATE AMINOTRANFERASE (AST)
K896000 · CIT
American Monitor Corp.
Chemistry · 90d
Cleared Jan 11, 1990
VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
K896046 · KMK
Vitaphore Corp.
General Hospital · 86d
Cleared Jan 11, 1990
35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM
K896049 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 85d
Cleared Jan 11, 1990
AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.
K896161 · FPA
3M Company
General Hospital · 79d
Cleared Jan 11, 1990
SKED STRETCHER
K896177 · FPP
Skedco, Inc.
General Hospital · 78d
Cleared Jan 11, 1990
SKED FLOTATION SYSTEM
K896179 · FPP
Skedco, Inc.
General Hospital · 78d
Cleared Jan 11, 1990
CENTURION KLEEN-NEEDLE SYSTEM
K896320 · FMI
Tri-State Hospital Supply Corp.
General Hospital · 71d
Cleared Jan 11, 1990
CMS IV FILTERS
K896333 · FPB
Churchill Medical Systems, Inc.
General Hospital · 69d
Cleared Jan 11, 1990
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · JIL
Boehringer Mannheim Corp.
Chemistry · 63d
Cleared Jan 11, 1990
REP(TM) SPE PLUS-30 PROCEDURES
K896572 · CFP
Helena Laboratories
Chemistry · 52d
Cleared Jan 11, 1990
HAND CONTROLLED ELECTROSURGICAL PENCILS
K896626 · GEI
Conmedcorp
General & Plastic Surgery · 51d
Cleared Jan 11, 1990
SOFT CORNEAL LIGHT SHIELD
K896681 · HOY
Visitec Co.
Ophthalmic · 45d
Cleared Jan 11, 1990
VISITEC MICRO-SPONGE SPEARS
K896705 · HOZ
Visitec Co.
Ophthalmic · 44d
Cleared Jan 11, 1990
I/A HANDPIECE
K896754 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 42d
Cleared Jan 11, 1990
SURGISMOKE
K896822 · FYD
Spectro Industries, Inc.
General Hospital · 38d
Cleared Jan 11, 1990
ALCOHOL PREP AND POVIDONE-IODINE PREP
K896835 · LKB
Norpak Mfg., Inc.
General Hospital · 37d
Cleared Jan 11, 1990
OPUS PHENOBARBITAL TEST SYSTEM
K896861 · DLZ
Pb Diagnostic Systems, Inc.
Toxicology · 37d
Cleared Jan 11, 1990
FOLLICLE STIMULATING HORMONE-EIA-XT
K896864 · CGJ
In Vitro Diagnostics, Inc.
Chemistry · 36d
Cleared Jan 10, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892287 · LYY
Supermax Sdn Bhd
General Hospital · 279d
Cleared Jan 10, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892562 · LYY
Yiu Tsun Industrial Co., Ltd.
General Hospital · 275d
Cleared Jan 10, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892702 · LYY
P.T. Daifatex Indah
General Hospital · 274d
Cleared Jan 10, 1990
LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE
K893217 · HIS
Shinhen Corp.
Obstetrics & Gynecology · 258d