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

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175,820 results
126313–126336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1990
MINT SCENTED CONDOMS
K900679 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 115d
Cleared Jun 07, 1990
CHEMOPLUS GLOVE
K901411 · LYY
Biosafety Systems, Inc.
General Hospital · 73d
Cleared Jun 07, 1990
MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS
K902019 · HDF
Gynescope Corp.
Obstetrics & Gynecology · 35d
Cleared Jun 07, 1990
CROAK OVARIAN BIOPSY FORCEP
K902049 · HFB
Gynescope Corp.
Obstetrics & Gynecology · 31d
Cleared Jun 07, 1990
ULTRA.SPEC NON-STERILE LATEX EXAMINATION GLOVE
K902282 · LYY
Ncl Corp.
General Hospital · 16d
Cleared Jun 07, 1990
CARRINGTON WOUND DRESSING
K902345 · FRO
Carrington Laboratories, Inc.
General & Plastic Surgery · 13d
Cleared Jun 06, 1990
RUBBER CONTRACEPTIVE (CONDOM)
K896142 · HIS
Guangzhou No. 11 Rubber Factory
Obstetrics & Gynecology · 225d
Cleared Jun 06, 1990
SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM
K896630 · KAM
Atos Medical AB
General & Plastic Surgery · 196d
Cleared Jun 06, 1990
RUBBER CONDOM (NON-COLORED)
K896987 · HIS
Hankook Latex Gongup Co., Ltd.
Obstetrics & Gynecology · 175d
Cleared Jun 06, 1990
PROMISE ABSORBENT PROTECTIVE PAD
K900421 · HHD
Scott Health Care
Obstetrics & Gynecology · 127d
Cleared Jun 06, 1990
WOUND TREATMENT KIT
K901109 · FRO
Orion Life Systems, Inc.
General & Plastic Surgery · 89d
Cleared Jun 06, 1990
HYPODERMIC SYRINGE LUER LOK
K901203 · FMF
Ware-Medics Glass Works, Inc.
General Hospital · 84d
Cleared Jun 06, 1990
RUBBER, DENTAL DAM (NON-STERILE)
K901236 · EIE
Naturub Sdn. Bhd.
Dental · 83d
Cleared Jun 06, 1990
BIPOLARD POLYPECTOMY SYSTEM (TM)
K901302 · GEI
Medical Devices, Inc.
General & Plastic Surgery · 78d
Cleared Jun 06, 1990
ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
K901362 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 75d
Cleared Jun 06, 1990
EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B
K901573 · DKB
Syva Co.
Toxicology · 63d
Cleared Jun 06, 1990
PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE
K901796 · ISA
Component Equipment Mfg., Inc.
Physical Medicine · 48d
Cleared Jun 06, 1990
REP(R) IMMUNOFIX
K901805 · DAH
Helena Laboratories
Immunology · 47d
Cleared Jun 06, 1990
SUPER STRENGTH DENTURE ADHESIVE CREAM
K901938 · KOB
Teledyne Getz
Gastroenterology & Urology · 37d
Cleared Jun 06, 1990
BLOOD GAS CONTROLS
K901985 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 35d
Cleared Jun 06, 1990
X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS
K901997 · IZH
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 35d
Cleared Jun 06, 1990
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
K902123 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Jun 06, 1990
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)
K902266 · JJR
Phoenix Diagnostics, Inc.
Chemistry · 16d
Cleared Jun 05, 1990
CONCEPT UNICOMPARTMENTAL KNEE SYSTEM
K896648 · HSX
Concept, Inc.
Orthopedic · 193d