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
131689–131712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891501 · LYY
Tan Chong Rubber Gloves Sdn Bhd
General Hospital · 15d
Cleared Mar 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891546 · LYY
Ap Intl., Inc.
General Hospital · 14d
Cleared Mar 31, 1989
PERCUSSION HAMMER
K891571 · GWZ
Sandal Surgico
Neurology · 11d
Cleared Mar 31, 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
K891697 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Mar 30, 1989
MICRODELTA II
K885242 · IYX
Siemens Gammasonics, Inc.
Radiology · 98d
Cleared Mar 30, 1989
GENNY DENNY IV SHIELD
K885342 · FMK
Mercury Enterprises, Inc.
General & Plastic Surgery · 92d
Cleared Mar 30, 1989
PATIENT EXAMINATION GLOVE
K890591 · LYY
Marcon Rubber Industry Sdn. Bhd.
General Hospital · 52d
Cleared Mar 30, 1989
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
K890724 · BZK
Bear Medical Systems, Inc.
Anesthesiology · 45d
Cleared Mar 29, 1989
SAFECON CONDOMS W/SPERMICIDAL LUBRICANT
K883524 · HIS
Quality Synthetics Intl, Inc.
Obstetrics & Gynecology · 224d
Cleared Mar 29, 1989
P.F.C.(TM) MODULAR KNEE SYSTEM
K884796 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 133d
Cleared Mar 29, 1989
ITE HEARING AID PARKER/TECHNITONE, MODEL PA
K884997 · ESD
Hearing Enhancement Center, Inc.
Ear, Nose, Throat · 118d
Cleared Mar 29, 1989
MULTI-PURPOSE CONTROL SYSTEM
K885140 · FLE
Colliers Sterilizer Sales & Service...
General Hospital · 104d
Cleared Mar 29, 1989
AQUADERM
K885205 · KGX
Laivan Corp.
General & Plastic Surgery · 100d
Cleared Mar 29, 1989
HUNTLEIGH DYNAMIC FLOTATION SYSTEM
K890012 · FNM
Huntleigh Technology, Inc.
General Hospital · 85d
Cleared Mar 29, 1989
TOITU DOPPLER FETUS DETECTOR, FD-400D
K890139 · KNG
Toitu of America, Inc.
Obstetrics & Gynecology · 75d
Cleared Mar 29, 1989
PHOSPHORIC-ACID ETCHING GEL
K890140 · EBF
Centrix, Inc.
Dental · 75d
Cleared Mar 29, 1989
BRACE (ORAFIX SPECIAL)
K890290 · ECB
Norcliff Thayer, Inc.
Dental · 69d
Cleared Mar 29, 1989
VITAACCESS CATHETER INTRODUCER KIT
K890435 · FOZ
Vitaphore Corp.
General Hospital · 61d
Cleared Mar 29, 1989
FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS
K890494 · EBC
Macrochem Corp.
Dental · 57d
Cleared Mar 29, 1989
GELLHORN PESSARY 33410 VARIOUS SIZES
K890565 · HHW
Medi-Source, Inc.
Obstetrics & Gynecology · 51d
Cleared Mar 29, 1989
RUBBER DAM
K890667 · EIE
Cost Rite Health Products, Inc.
Dental · 48d
Cleared Mar 29, 1989
PATIENT EXAMINATION GLOVES
K890816 · LYY
Dan Co., Ltd.
General Hospital · 40d
Cleared Mar 29, 1989
ALADAN STERILE LATEX MEDICAL GLOVE
K890880 · LYY
Aladan Corp.
General Hospital · 36d
Cleared Mar 29, 1989
VINYL PATIENT EXAMINATION GLOVE
K890985 · LYZ
Am Gloves Co., Ltd.
General Hospital · 28d