FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
128257–128280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 10, 1990
DENTAL ENDODONTIC CEMENT (MODIFICATION)
K894092 · KIF
The Hygenic Corp.
Dental · 216d
Cleared Jan 10, 1990
LATEX EXAMINATION GLOVES
K894376 · LYY
P.T. Haluwiko Pratita
General Hospital · 177d
Cleared Jan 10, 1990
PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH
K894437 · FRG
Clive Craig Co.
General Hospital · 177d
Cleared Jan 10, 1990
INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM
K894477 · EMA
Cosmedent, Inc.
Dental · 176d
Cleared Jan 10, 1990
PATIENT EXAMINATION GLOVES
K895228 · LYY
Ray Intl. Co.
General Hospital · 148d
Cleared Jan 10, 1990
LATEX PATIENT EXAMINATION GLOVES
K895237 · LYY
China Shanghai SI DA Latex & Plastics...
General Hospital · 142d
Cleared Jan 10, 1990
CHARISE CHARLES REAGENT STRIPS
K895282 · JIL
Lee Import Domestic Consulting
Chemistry · 139d
Cleared Jan 10, 1990
NOVA PILLOW
K895477 · IQK
Nova Health Systems, Inc.
Physical Medicine · 121d
Cleared Jan 10, 1990
SANI-PIKS DENTAL HAND INSTRUMENT
K895985 · EKJ
Bison-Lee Co.
Dental · 89d
Cleared Jan 10, 1990
MEDICAL DISPOSABLE BEDDING
K896042 · IQK
Keystone Veterinary Supplies, Inc.
Physical Medicine · 86d