FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

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

5,198 results for "health"
4657–4680 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 28, 1988
TENSTAR
K874818 · GZJ
Healthcheck Corp.
Neurology · 309d
Cleared Sep 23, 1988
SAFESITE INJECTION SITE AND BLUNT CANNULA
K883638 · FPA
Baxter Healthcare Corp
General Hospital · 29d
Cleared Sep 12, 1988
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · FER
Baxter Healthcare Corp
Gastroenterology & Urology · 158d
Cleared Sep 09, 1988
DADE TDM CONTROL
K883190 · DIF
Baxter Healthcare Corp
Pathology · 43d
Cleared Sep 07, 1988
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
K883394 · JWY
Baxter Healthcare Corp
Microbiology · 27d
Cleared Sep 07, 1988
GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS
K883076 · JWY
Baxter Healthcare Corp
Microbiology · 56d
Cleared Sep 06, 1988
RK2000 K-THERMIA SYSTEM
K882442 · DWJ
Baxter Healthcare Corp
Cardiovascular · 84d
Cleared Sep 06, 1988
ZEPHYR
K880534 · FXX
Racal Health & Safety, Inc.
General Hospital · 210d
Cleared Aug 29, 1988
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795 · JJT
Baxter Healthcare Corp
Chemistry · 54d
Cleared Aug 23, 1988
SUTURE RETENTION DEVICE
K883299 · KGS
Edwards Orthopaedics Div., Baxter...
General & Plastic Surgery · 19d
Cleared Aug 15, 1988
FASTIDIOUS INOCULUM BROTH
K883075 · JSD
Baxter Healthcare Corp
Microbiology · 33d
Cleared Aug 03, 1988
AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER
K883018 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 15d
Cleared Aug 02, 1988
CATHETER STRAP
K881781 · KOD
Baxter Healthcare Corp
Gastroenterology & Urology · 98d
Cleared Jul 22, 1988
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA
K882680 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 23d
Cleared Jul 18, 1988
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
K882438 · BXN
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 34d
Cleared Jul 13, 1988
EXTENDED LIFE CAPD TRANSFER SET 5C4444
K882498 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 26d
Cleared Jul 13, 1988
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
K882455 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 29d
Cleared Jul 08, 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503 · JJY
Baxter Healthcare Corp
Chemistry · 88d
Cleared Jul 05, 1988
ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.
K882104 · JGS
Paramax Systems Div. Baxter Healthcare
Chemistry · 47d
Cleared Jun 24, 1988
NASAL CPAP SYSTEM
K881833 · BYE
Healthdyne, Inc.
Anesthesiology · 56d
Cleared Jun 22, 1988
HEALTHTRONIC OMEGA TRAC
K881902 · JFB
Healthtronics Surgical Services, Inc.
Physical Medicine · 47d
Cleared Jun 20, 1988
EXTENDED LIFE INJECTION SITE
K882007 · FPA
Baxter Healthcare Corp
General Hospital · 38d
Cleared Jun 16, 1988
DISPOSABLE SYRINGE
K882335 · FMF
Baxter Healthcare Corp
General Hospital · 10d
Cleared Jun 16, 1988
BLOOD/SOLUTION SET W/PRESSURE PUMP
K881321 · FPA
Baxter Healthcare Corp
General Hospital · 79d